Governing Body matters: key issues arising out of the seventy-fifth World Health Assembly and the 150th and 151st sessions of the WHO Executive Board

REGIONAL COMMITTEE Provisional Agenda item 10.1 Seventy-fifth Session SEA/RC75/15 Paro, Bhutan 5−9 September 2022 29 July 2022 Governing Body matters: Key issues arising out of the Seventy-fifth World Health Assembly and the 150th and 151st sessions of the WHO Executive Board This Working Paper highlights, from the perspective of the WHO South-East Asia Region, the resolutions endorsed, and decisions adopted, by the Seventy-fifth World Health Assembly (held on 22–28 May 2022) and the 150th and 151st sessions of the WHO Executive Board (held on 24–29 January 2022 and 30 May 2022, respectively) along with other important Agenda items. The issues are deemed to have important implications for the Member States of the WHO South-East Asia Region and the resolutions/decisions merit follow-up action by both Member States of the Region as well as the Organization at the regional and country levels. The background of the selected resolutions/decisions, their implications on WHO’s collaborative activities with Member States, as applicable, along with actions proposed for Member States and WHO, have been summarized. All the related resolutions/decisions/ working papers along with the text of the ‘Regional One Voice’ presented at the Seventy- fifth World Health Assembly by the delegation of the Member States of the WHO South- East Asia Region on select Agenda items, as applicable, are provided in the annex to this Working Paper. The High-Level Preparatory Meeting held virtually in New Delhi on 18–20 July 2022 reviewed the attached Working Paper and noted the provisions of the selected resolutions endorsed and decisions adopted by the Seventy-fifth World Health Assembly and the 150th and 151st sessions of the WHO Executive Board and other Agenda items deemed to have important implications for the WHO South-East Asia Region and merit follow-up actions at the regional and country levels. The HLP Meeting, following a review of the document, made the following recommendations. Action by Member States (1) To implement the related provisions of the selected resolutions endorsed and Decisions adopted by the Seventy-fifth World Health Assembly and the 150th and 151st sessions of the WHO Executive Board which merit follow-up actions at the regional as well as country level. Action by WHO (1) To take appropriate follow-up actions at the regional and country levels to support Member States in the implementation of actionable provisions of the World Health Assembly and Executive Board resolutions and Decisions. The Working Paper and recommendations of the HLP Meeting are submitted to the Seventy-fifth Session of the WHO Regional Committee for South-East Asia for its consideration. CONTENTS Page No. 1) Follow-up to the Political Declaration of the third High-Level Meeting of the UN General Assembly on the prevention and control of noncommunicable diseases: (g) Draft intersectoral Global Action Plan on epilepsy and other neurological disorders in support of universal health coverage _____________________________________________________________________ 1 2) Follow-up to the Political Declaration of the third High-Level Meeting of the General Assembly on the prevention and control of noncommunicable diseases: (h) Draft Action Plan (2022–2030) to effectively implement the Global Strategy to reduce the harmful use of alcohol as a public health priority_________________________________________________ 3 3) The Global Health Sector Strategies on, respectively, HIV, viral hepatitis and sexually transmitted infections________________________________________________ 6 4) Roadmap for neglected tropical diseases 2021–2030 ________________________________ 8 5) Immunization Agenda 2030 ____________________________________________________ 10 6) Infection prevention and control ________________________________________________ 12 7) Global roadmap on defeating meningitis by 2030 __________________________________ 15 8) Standardization of nomenclature of medical devices ________________________________ 17 9) Outcome of the Special Session of the World Health Assembly held to consider developing a WHO convention, agreement or other international instrument on pandemic preparedness and response ____________________ 19 10) Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination ______________________ 21 11) Implementation of the International Health Regulations (2005) _______________________ 22 12) Influenza preparedness ________________________________________________________ 25 13) Global Health for Peace Initiative ________________________________________________ 28 14) Polio transition planning and polio post-certification ________________________________ 30 15) WHO Implementation Framework for the Billion 3 – Outcome of the SIDS Summit for Health: For a healthy and resilient future in small island developing states _____________________________________________________________ 32 16) WHO Implementation Framework for Billion 3 – Well-being and health promotion __________________________________________________________________ 34 17) WHO Global Strategy for food safety ____________________________________________ 38 18) Prevention of sexual exploitation, abuse and harassment ____________________________ 40 19) Global Strategy and plan of action on public health, innovation and intellectual property __________________________________________________________ 43 20) Traditional medicine __________________________________________________________ 46 21) Public health dimension of the world drug problem ________________________________ 48 22) Standing Committee on Health Emergency (Pandemic) Prevention, Preparedness and Response ____________________________________________________ 50 Annexures 1) Resolutions and Decisions of the Seventy-fifth World Health Assembly (which also cover the subjects of technical resolutions adopted by the 150th and 151st sessions of the Executive Board). 2) Regional One Voice (RoV) intervention(s) on select Agenda items delivered by Member States of the SE Asia Region during the Seventy-fifth World Health Assembly. 3) Report by the WHO Director-General on select Agenda items submitted to the Seventy-fifth World Health Assembly. SEA/RC75/15 Page i Introduction 1. The Seventy-fifth World Health Assembly in May 2022 and the 150th and 151st sessions of the WHO Executive Board in January 2022 and May 2022 respectively endorsed a number of resolutions and decisions during the course of their deliberations. These decisions and resolutions relate to health matters as well as Programme Budget and financial matters. 2. The summaries of resolutions and decisions on technical matters that have significant implications for the South-East Asia Region along with other important Agenda items are presented in this Working Paper. Salient information on the implications of the issues, and actions already taken and/or yet to be taken, are also included herein. 3. Also annexed to this Working Paper are copies of all the relevant resolutions and decisions adopted by the Seventy-fifth World Health Assembly, the Director-General’s report on select Agenda items presented to the Assembly and the text of the “Regional One Voice” statements delivered at the Seventy-fifth Health Assembly by the delegation of the Member States of the South-East Asia Region on select Agenda items, as applicable (these also cover the subjects of technical resolutions adopted by the 150th and 151st sessions of the Executive Board).

SEA/RC75/15 1) Follow-up to the Political Declaration of the third High-Level Meeting of the UN General Assembly on the prevention and control of noncommunicable diseases: (g) Draft intersectoral Global Action Plan on epilepsy and other neurological disorders in support of universal health coverage Background 1. Neurological disorders are the leading cause of disability and the second leading cause of death. The five largest contributors are stroke, migraine, dementia, meningitis and epilepsy. Much of the neurological disease burden is preventable, provided that broad public health responses in maternal and newborn health care, communicable disease control, injury prevention and cardiovascular health, are implemented. 2. Challenges and gaps in providing care and services for people with neurological disorders exist worldwide, and more so in low- and middle-income countries. At the resumed session of the Seventy-third World Health Assembly in November 2020, Member States endorsed resolution WHA73.10 titled “Global actions on epilepsy and other neurological disorders” calling for scaled-up and integrated action on epilepsy and other neurological disorders. Member States also asked for a 10-year intersectoral Global Action Plan to be developed for consideration at the Seventy-fifth World Health Assembly. 3. Accordingly, the intersectoral Global Action Plan on epilepsy and other neurological disorders (2022–2031), developed in response to global resolutions, decisions, reports and commitments (including resolution WHA68.20 titled “Global burden of epilepsy and the need for coordinated action at the country level to address its health, social and public knowledge implications”), was endorsed by the Seventy-fifth World Health Assembly. 4. The intersectoral Global Action Plan on epilepsy and other neurological disorders will address the gaps through integration of prevention, diagnosis, treatment and rehabilitation measures for neurological disorders within primary health care, which is critical to achieving universal health coverage. Main operative paragraph and implications on the collaborative activities with Member States 5. The WHO Regional Office for South-East Asia attaches great importance in containing NCDs including epilepsy and neurological disorders. Prevention and control of NCDs is one of the eight Regional Flagship Priority Programmes of the Region. The Regional Office continues to provide technical support to Member States to build capacity in addressing the huge treatment gap in epilepsy and neurological disorders. SEA/RC75/15 Page 2 Actions already taken in the Region 6. In July 2021, the Regional Office coordinated the discussion of the draft intersectoral Global Action Plan on epilepsy and neurological disorders with regional experts, country focal persons and nongovernmental organizations (NGOs). The draft was further reviewed internally by the technical teams at the SE Asia Regional and country offices with the technical team from WHO Headquarters through several online sessions. 7. The Regional Office has also published several documents on epilepsy and neurological disorders. These include: • Addressing mental and neurological disorders: Impact evaluation of ongoing projects to strengthen primary health care – Report of the regional meeting of experts, December 2011; • Meeting of experts on community-based approaches to autism, November 2011; • Strengthening primary care to address mental and neurological disorders, November 2013; • Promotion of mental well-being: pursuit of happiness, November 2013; and • Ageing gracefully: diversity of dementia, June 2021. 8. The Regional Office regularly engages Member States through several regional-level workshops and consultation meetings and through distribution of publications on the subject. The Regional Office also collaborates closely with other international organizations such as the International League Against Epilepsy and the International Bureau for Epilepsy. Actions to be taken in the Region 9. The Regional Office has established a Regional Expert Group of 12 members including academics, opinion leaders, clinicians and public health experts from the Region and globally. The group will provide critical guidance and advice in moving forward the agenda of mental health, neurological disorders and substance use in the Region. 10. The Regional Office will provide necessary technical support and context-specific guidance for adoption, adaptation and implementation of the Intersectoral Global Action Plan on epilepsy and other neurological disorders. SEA/RC75/15 Page 3 2) Follow-up to the Political Declaration of the third High-Level Meeting of the General Assembly on the prevention and control of noncommunicable diseases: (h) Draft Action Plan (2022–2030) to effectively implement the Global Strategy to reduce the harmful use of alcohol as a public health priority Background 11. In 2019, the Seventy-second World Health Assembly (vide decision WHA72(11)) extended the WHO’s Global Action Plan for the prevention and control of noncommunicable diseases (NCD-GAP) 2013–2020 to 2030, ensuring its alignment with the 2030 Agenda for the Sustainable Development Goals. The NCD-GAP lists harmful use of alcohol as one of four key risk factors for major NCDs. It enables Member States and other stakeholders to identify and use opportunities for synergies to tackle more than one risk factor at the same time; strengthen coordination and coherence between measures for reducing the harmful use of alcohol and activities for preventing and controlling NCDs; and set voluntary targets for reducing the harmful use of alcohol and other risk factors for NCDs. 12. The 150th session of the Executive Board, in its decision EB150(4), recommended to the Seventy-fifth World Health Assembly to adopt the Action Plan 2022–2030 to effectively implement the Global Strategy to reduce the harmful use of alcohol as a public health priority. After detailed deliberations on the NCDs agenda and as recommended by the Executive Board, the Seventy-fifth World Health Assembly adopted Decision WHA75(11).1 During the discussions on the proposed agenda and the Action Plan, more than 23 countries deliberated on the resolution, including three countries from the SE Asia Region – Indonesia, Sri Lanka and Thailand. Main operative paragraph and implications on the collaborative activities with Member States 13. Since the endorsement of the Global Strategy, its implementation has been uneven across WHO regions as well as within the regions and countries. The number of countries with a written national alcohol policy has steadily increased and many countries have revised their existing alcohol policies. However, considerable challenges remain for the implementation of effective alcohol policies. 14. These challenges relate to the complexity of the problem; differences in cultural norms and contexts; the intersectoral nature of cost-effective solutions, including pricing strategies; associated limited levels of political will and leadership at the highest levels of government; and the influence of powerful commercial interests on policy-making and implementation. 1 Follow-up to the Political Declaration of the Third High-Level Meeting of the General Assembly on the prevention and control of noncommunicable diseases. Doc No. WHA75(11). Geneva: World Health Organization, 2022. https://apps.who.int/gb/ebwha/pdf_files/WHA75/A75(11)-en.pdf – accessed 27 June 2022 SEA/RC75/15 Page 4 15. These challenges operate against a background of competing international economic commitments. The limited availability of comprehensive and reliable data on alcohol consumption and related harm, generated at the national level, presents additional challenges for the evaluation of the impact of implemented national policy responses in many countries. Coordination and cooperation at all levels for dealing with these challenges is further complicated by contexts in which the responsibility for actions to reduce the harmful use of alcohol is dispersed between different entities, including government departments and varied professions and technical areas. 16. During the Seventy-fifth World Health Assembly, countries from the SE Asia Region called for more investment and greater priority to be allocated to support the development and implementation of effective policies and actions in the Region. They expressed their concerns about rising alcohol use among youth, pervasive advertising and industry influence and lack of effective countermeasures against aggressive advertisement and commercial determinants. Absence of or weak intercountry treaties and regulations to curb cross-border trade and smuggling further compound the problem. Lessons learnt from tobacco control through the WHO Framework Convention on Tobacco Control (WHO FCTC) provide important lessons learnt for the Global Framework on alcohol control with binding international treaties that regulate alcohol trade, health warnings on alcohol bottles, more efficient data collection, analysis and use, concerted efforts for demand reduction through engagement of civil society as well as treatment and rehabilitation of people who are dependent on alcohol. Actions already taken in the Region 17. The Regional Office continues to provide technical support to Member States in the prevention and reduction of harm due to alcohol through advocacy and raising awareness, capacity-building and provision of evidence-based information and dissemination of global and regional guidance. 18. During the COVID-19 pandemic, in response to a surge in online advertising and supply of home alcohol, the Regional Office ran an online campaign on alcohol-related harm, support and care-seeking for those in need. The Regional Office also facilitated the survey on alcohol and tobacco taxation and use during the COVID-19 pandemic. 19. More than 10 technical publications on alcohol and related topics were produced and released during the last six years. These include: a. Regional Action Plan to implement the Global Strategy to reduce harmful use of alcohol for the South-East Asia Region (2014–2025), June 2021; b. Prevention of drug use in schools, July 2021; c. Voice of the Children: Alcohol in the eyes of the young, August 2019; d. Epidemiology of alcohol use in the WHO South-East Asia Region, January 2018; e. A Report on Alcohol Policy in the WHO South-East Asia Region, November 2017; f. Reducing harm from alcohol use: good practices, May 2016; SEA/RC75/15 Page 5 g. Mental health and substance abuse, including alcohol in the South-East Asia Region of WHO – Public health problems caused by harmful use of alcohol: gaining less or losing more?, April 2016; h. Burden and socioeconomic impact of alcohol: the Bangalore study, April 2016; i. Alcohol control policies in the South-East Asia Region: selected issues, April 2016; and j. Alcohol use and abuse, what you should know, April 2016. Actions to be taken in the Region 20. The Regional Office will continue to advocate with and urge Member States to prioritize and invest more in reducing alcohol-related harm including on health, social relationships and economic losses, and provide technical support for implementation of the Global Action Plan on reducing harm related to alcohol 2020–2030. SEA/RC75/15 Page 6 3) The Global Health Sector Strategies on, respectively, HIV, viral hepatitis and sexually transmitted infections Background 21. In response to Decision WHA74(20) adopted by the Seventy-fourth World Health Assembly, the draft Global Health Sector Strategies (GHSS) on HIV, viral hepatitis and sexually transmitted infections, 2022–2030, developed through a broad consultative process, were submitted to the 150th session of the WHO Executive Board. The Board decided that informal consultations will continue with a view to submit a revised final draft to the Seventy-fifth World Health Assembly. 22. The Seventy-fifth World Health Assembly was informed that informal and formal consultations with Member States had been held on issues pertaining to and the terminologies used for certain issues such as “sexual orientation”, “gender identification”, and “comprehensive sexuality education”, through a series of deliberations until April 2022, with opportunities made available for providing written feedback. Accordingly, a revised final version was shared in the public domain on 1 May 2022 and presented to the Health Assembly. Main operative paragraph and implications on the collaborative activities with Member States 23. Member States, mostly from the Eastern Mediterranean Region proposed an amendment to remove the glossary from the scheduled annexes of the GHSS, and to add footnotes which broadly allowed to mention that countries’ adoption of sexual orientation, as mentioned in GHSS, will be in line with national legislations, and that the guidelines on comprehensive sexuality education referred to in the GHSS are yet to reach international consensus. 24. While calling for consensus, Mexico, backed by several other countries expressed disagreement with the above amendment and moved another amendment proposing three statements: (1) notes with appreciation the GHSS on, respectively, HIV, viral hepatitis and sexually transmitted infections, (2) reaffirms that in implementing the GHSS, the national contexts should be considered; and (3) requests the Director-General to report on the progress in 2024, 2026, 2028 and 2031, noting that the 2026 report will provide a mid-term review based in meeting the strategies’ 2025 targets towards achieving the 2030 goals. 25. Following extensive discussions and voting, the former amendment was rejected. Finally, the Decision on the Strategies was adopted by the World Health Assembly. Out of 183 Member States scheduled to vote, 30 were not present and 90 decided not to vote (though present). Of the 63 that voted, 61 voted in favour and two against. 26. The Seventy-fifth World Health Assembly (vide its resolution WHA75.20), noted with appreciation, the Global Health Sector Strategies on, respectively, HIV, viral hepatitis and sexually transmitted infections, for the period 2022–2030. The Director-General was requested for regular reporting to the Assembly during the implementation period. SEA/RC75/15 Page 7 Actions already taken in the Region 27. Following a proposal submitted by Indonesia, the Seventy-fourth Session of the Regional Committee for South-East Asia adopted Decision SEA/RC74(4)2 that requested the Regional Director to undertake a consultative process to develop an integrated Regional Action Plan (RAP) on viral hepatitis, HIV and STIs for 2022–2026, in alignment with the SDGs and GHSS, for the consideration of and endorsement by the Seventy-fifth Session of the Regional Committee in 2022. 28. Following the decision, the Secretariat organized wide-ranging consultations with Member States, communities and partners, and also through online surveys. Feedback received was incorporated and the revised draft of the RAP was shared again with Member States for further inputs from them to be submitted by 5 June 2022. 29. In preparing the draft RAP, utmost care has been taken to avoid any of the potentially controversial terms and terminology that lacked consensus among Member States at the Seventy- fifth World Health Assembly. None of the Member States from the Region have expressed any disagreement with the terms used in and tenor of the draft shared with them. Actions to be taken in the Region 30. In line with Decision SEA/RC74(4) of the Seventy-fourth session of the Regional Committee, the integrated Regional Action Plan for hepatitis, HIV and sexually transmitted infections for the period 2022–2026 has been finalized and is being submitted to the Seventy- fifth Session of the WHO Regional Committee for South-East Asia for adoption and dissemination. 31. The WHO Secretariat will provide contextually relevant technical support to Member States for advancing key actions in the Regional Action Plan towards the elimination targets and will submit a progress report to the Regional Committee in 2024 and 2026. 2 Beginning of the Decade of Action for ending viral hepatitis, HIV and STIs as public health threats by 2030 in the South-East Asia Region. Doc No. SEA/RC74(4). New Delhi: World Health Organization, Regional Office for South-East Asia, 2021. https://apps.who.int/iris/bitstream/handle/10665/345273/sea-rc74-decisions-eng.pdf?sequence=1&isAllowed=y – accessed 23 June 2022. SEA/RC75/15 Page 8 4) Roadmap for neglected tropical diseases 2021–2030 Background 32. On 13 November 2020, the Seventy-third World Health Assembly adopted Decision WHA73(33) on “Roadmap for neglected tropical diseases 2021–2030”, by which it endorsed the new Roadmap for neglected tropical diseases 2021–2030, and requested the Director-General, inter alia, to report biennially to the Health Assembly, through the Executive Board, on the implementation of the Roadmap. 33. The new Roadmap, “Ending the neglect to attain the Sustainable Development Goals: a roadmap for neglected tropical diseases 2021–2030,”3 was launched by WHO on 30 January 2021, coinciding with World Neglected Tropical Diseases Day. 34. The Roadmap’s key features include: • It is designed to address critical gaps across multiple NTD programmes by integrating and mainstreaming approaches and actions within national health systems, and across sectors. • It also provides opportunities to evaluate, assess and adjust programmatic actions as needed over the next decade, by setting clear targets and milestones. • It moves away from the vertical, disease-centred approach to being people-focused. 35. The report provided data on indicators as of end 2020, only because most information for 2021 – the first year of the new Roadmap – will be available only later in 2022. Thus, these data are considered as the baseline for the new Roadmap. Main operative paragraph and implications on the collaborative activities with Member States 36. The Executive Board at its 150th session noted the report on the Roadmap for neglected tropical diseases 2021–2030. During the discussions, the Board members drew attention to the impact of the COVID-19 pandemic on services that address neglected tropical diseases. Renewed efforts of Member States were needed to keep the Roadmap’s targets for neglected tropical diseases on track and ensure that services for those diseases remained a part of basic health care. Actions already taken in the Region 37. Despite the COVID-19 pandemic, key interventions for preventive chemotherapy for select NTDs were delivered in seven of the 11 Member countries endemic for NTDs during 2021 with support of WHO and other donors and partners. 3 Ending the neglect to attain the Sustainable Development Goals: a roadmap for neglected tropical diseases 2021–2030. Geneva: World Health Organization, 2020. https://www.who.int/publications/i/item/9789240010352 – accessed 23 June 2022 SEA/RC75/15 Page 9 38. Following the resolution, work began for the development of the new Regional Strategy for accelerating and sustaining kala-azar elimination in the South-East Asia Region 2022–2026 and the Action Plan for the control and prevention of snakebite envenoming in the South-East Asia Region 2022–2030 in line with the NTD Roadmap, through a consultative process with Member States, Regional Technical Advisory Groups (RTAG) and partners. 39. During the COVID-19 pandemic, the WHO Secretariat also continued to provide technical support to Member States and convened a series of meetings of the RTAG, and of experts and programme managers, including the RTAGs for dengue and kala-azar, the Regional Programme Review Groups for lymphatic filariasis, soil-transmitted helminth (STH) and schistosomiasis, and a Regional Consultation on yaws. Actions to be taken in the Region 40. The WHO Secretariat will continue to advocate for renewed efforts by Member States to catalyse innovation through a regional partnership of Member States, donors and stakeholders, and to provide contextually relevant technical support to Member States for advancing control and elimination of NTDs in the Region in line with the NTD Roadmap. SEA/RC75/15 Page 10 5) Immunization Agenda 2030 Background 41. The Seventy-third World Health Assembly in 2020 adopted Decision WHA73(9) to endorse the new global vision and overarching strategy for vaccines and immunization that is contained in the Immunization Agenda 2030, or IA 2030. 42. At the Seventy-fourth World Health Assembly in May 2021, Member States expressed support for the implementation of IA 2030 through the Framework for Action. The Framework for Action detailed how coordinated operational planning, monitoring and evaluation, ownership and accountability, and communications and advocacy are key drivers for implementation and impact on the ground. 43. The Global Report on IA 2030 for 2021 was presented to the Seventy-fifth World Health Assembly. It included the baseline data that will be used to track progress in immunization up to 2030, as well as progress in implementation at country, regional and global levels. All Member States extended support for the implementation of IA 2030 and the Health Assembly noted the report. Main operative paragraph and implications on the collaborative activities with Member States 44. Since 2010, major progress has been made in the SE Asia Region in the quest to achieve the targets of the Regional Vaccine Action Plan 2016–2021. Some of the significant successes in this regard have been maintaining polio-free status for the Region, sustaining elimination of maternal and neonatal tetanus in all countries, elimination of measles in three countries (Bhutan, DPR Korea and Timor-Leste), elimination of measles and rubella in two countries (Maldives and Sri Lanka) and verification of four countries for achieving hepatitis B control (Bangladesh, Bhutan, Nepal and Thailand). 45. Immunization coverage with the third dose of diphtheria–tetanus–pertussis vaccine (DTP3) had increased to 91% in 2019. This is the highest-ever immunization coverage achieved in the Region and all countries except Indonesia achieved DTP3 coverage of 90% or higher. However, the COVID-19 pandemic tangibly affected routine immunization services and vaccine- preventable disease surveillance in the Region. The DTP3 coverage decreased from 91% in 2019 to 85% in 2020 and more children became vulnerable to vaccine-preventable diseases. 46. Ten of the 11 countries rolled out COVID-19 vaccines in 2021. By the first week of July 2022, 64.1% of the entire population had received the primary doses of COVID-19 vaccines. And all 10 countries have reached the milestone of providing primary doses of the vaccine to 40% of the total population while four countries have reached the target of vaccinating 70% of their population. SEA/RC75/15 Page 11 Actions already taken in the Region 47. The Strategic Framework of the SE Asia Region Vaccine Action Plan 2022–2030 as aligned with IA 2030 has been developed in consultation with national immunization programmes and partners and was endorsed by the Regional Committee at its Seventy-fourth session in 2021. 48. The SE Asia Region Vaccine Implementation Plan (RVIP) for the period 2022–2026 has been developed under the umbrella of the Strategic Framework, in collaboration with Member States and partners. 49. In 2022, all countries have taken specific actions to vaccinate children and mothers who had missed routine immunization during the pandemic. The Regional Office and WHO country offices provide technical assistance and monitor the achievements monthly. Actions to be taken in the Region 50. The immediate priority is to bring routine immunization coverage to pre-pandemic levels and close the immunity gaps that have been created during the pandemic through catch-up campaigns. COVID-19 vaccination will remain an important priority and integration of COVID- 19-related and other routine immunization activities will be planned. Countries will be supported to align their multiyear immunization plans with the Regional Vaccine Implementation Plan 2022–2026. 51. National immunization programmes and national immunization technical advisory groups will send yearly reports to the Regional Immunization Technical Advisory Group (ITAG) meeting to be conducted in August 2022. Based on these reports ITAG will provide recommendations to the Regional Office and countries. The Regional Office through the Regional Working Group for Immunization Mechanism will coordinate partner support to implement the recommendations. SEA/RC75/15 Page 12 6) Infection prevention and control Background 52. The importance of infection prevention and control (IPC) in national health programmes is increasingly being recognized. The United Nations’ Sustainable Development Agenda 2030 and its universal targets related to health and well-being (including maternal, neonatal and child mortality, HIV-AIDS, tuberculosis, waterborne diseases, other communicable diseases, access to safe medical products, UHC and WASH) are all conspicuously impacted by IPC. Patient safety, health worker safety, prevention of antimicrobial resistance and health-care acquired infections and the Global Health Security Agenda have all underscored the importance of IPC. 53. Investing in infection prevention and control is one of the most effective and cost-saving interventions available for safe care. Available data show that around 70% health-care associated infections can be averted by enforcing proper IPC measures. Hand hygiene and environmental hygiene in hospitals reduces the risk of mortality, morbidity and complications caused by multidrug-resistant pathogens by about 40%. 54. The Director-General’s report presented to the 150th session of the WHO Executive Board in January 2022 summarized the status of IPC. The Board members underscored the importance and urgency of developing a Global Infection Prevention and Control Strategy to accelerate progress on implementation and monitoring in this area. 55. The Seventy-fifth World Health Assembly adopted the resolution WHA75.13,4 titled “Global Strategy on infection prevention and control”. The resolution was supported by Member States from all regions. From the South-East Asia Region, Bangladesh, Indonesia, Maldives and Thailand supported the resolution and Maldives also co-sponsored the event. Main operative paragraph and implications on the collaborative activities with Member States 56. IPC has been accorded greater importance since the outbreak of the COVID-19 pandemic. IPC measures such as hand hygiene, social distancing, use of masks and PPEs as well as the provision of training on IPC for health workers have proven to have helped Member States to prevent and reduce the spread of the pandemic as well as other infections. 57. The 2021 WHO Global Survey on minimum requirements for infection prevention and control (IPC) programmes at the national level showed that six of the 11 Member States in the SE Asia Region had an active IPC programme, guidelines and dedicated budget, and a third of them had a national IPC focal point. Four out of every five countries which participated in the survey globally had plans in place for health-care associated infection surveillance and around 67% of countries had reporting and feedback mechanisms operational (Global Report on IPC 2022). 4 Global Strategy on infection prevention and control. Doc. No. WHA75.13. Geneva: World Health Organization, 2022. https://apps.who.int/gb/ebwha/pdf_files/WHA75/A75_R13-en.pdf – accessed 27 June 2022 SEA/RC75/15 Page 13 58. Typically, IPC is addressed independently under several health programmes. However, the majority of Member States do not have an integrated IPC plan that includes national IPC policy, strategy, implementation frameworks, and programmes with designated IPC focal points that should help advance IPC. Actions already taken in the Region 59. The following actions have already been taken in the SE Asia Region: • Member States have participated in the global minimum IPC WHO core component requirements survey. • The WHO Regional Office has submitted its contributions to the Global IPC Report 2022. • International Hand Hygiene Day was observed with full rigour by WHO and Member States on 5 May 2022. • Virtual IPC global training modules/guidance documents have been developed and prepared by WHO. 60. The following meetings/consultations have also been held in the Region: • Virtual Informal Regional Consultation to align the Global Patient Safety Action Plan 2021–2030 (GPSAP) with the WHO Regional Strategy for patient safety in the WHO South-East Asia Region (2016–2025), 31 March–1 April 2021; • Virtual Regional Informal Consultation on implementing the Global Patient Safety Action Plan 2021–2030 (GPSAP), 25–26 April 2022; • Virtual training on quality in testing transfusion-transmitted infections in blood, 27–29 April 2022; and • Virtual training on patient safety incident reporting and learning systems in Maldives, 19 & 28 April 2022. Actions to be taken in the Region 61. The following actions are proposed to be taken in the Region: • Member States are due to participate in the consultative process to draft the Global IPC Strategy. • Member States will ensure the implementation of the minimum requirements (core components) for IPC at each level of their health-care systems. • Member States will strive towards the establishment of HAI surveillance at the national level. • An integrated approach with programmes such as AMR, quality of care, patient safety, WASH, UHC, health emergencies, blood safety, tuberculosis, acute respiratory infections, VPDs, STIs, MNCAH, etc. as appropriate, will be adopted for the national contexts by the Member States. SEA/RC75/15 Page 14 • Member States will also ensure that IPC is a part of the curriculum for the continuous medical education (CME) of national medical/health-care workers. • WHO and Member States also plan to conduct in collaboration advocacy and awareness activities on the availability of clean, quality, affordable care at each level. These will involve policy-makers, health-care workers and the community. 62. The Regional Office will consult with Member States through regional/global consultations or through the online portals to provide inputs towards the: • development of the draft Global IPC Strategy for submission to the Seventy-sixth World Health Assembly in 2023 through the 152nd Session of the WHO Executive Board in January 2023; • development of the draft IPC Global Action Plan based on the Global Strategy for submission to the Seventy-seventh World Health Assembly in 2024; and • reporting on progress and results to the Seventy-eighth World Health Assembly in 2025 and thereafter every two years until 2031. SEA/RC75/15 Page 15 7) Global Roadmap on defeating meningitis by 2030 Background 63. Meningitis is a deadly and debilitating disease with serious health, economic and social consequences. It affects people of all ages in all countries of the world. Bacterial meningitis can cause epidemics and lead to death within 24 hours of infection and, when they do not become a cause of death, leave one in five persons affected with lifelong disability after infection. However, many cases and deaths are preventable through vaccination and effective vaccines are either available or are under development. 64. The first Global Roadmap on defeating meningitis by 2030 set out a path to tackle the main causes of acute bacterial meningitis (meningococcus, pneumococcus, haemophilus influenzae (Hib) and group B streptococcus). This focus is based on: (i) evidence that these four organisms were responsible for over 50% of the 290 000 deaths from all causes of meningitis in 2017; and (ii) the impact that this draft Global Roadmap could have on diminishing the burden of disease by 2030. 65. The three visionary goals of the draft Global Roadmap to be achieved by 2030 are to: • eliminate epidemics of bacterial meningitis; • reduce the number of cases and deaths from vaccine-preventable bacterial meningitis; and • reduce disability and improve quality of life after meningitis due to any cause. Main operative paragraph and implications on the collaborative activities with Member States 66. In January 2022, during the 150th session of the Executive Board, Member States reviewed the progress in the implementation of the Roadmap (Report by the Director-General to the 150th session of the Executive Board – EB150/13). They expressed support for the establishment of a strategic support group to facilitate the implementation of the Roadmap and emphasized the relevance of strengthening the integration of meningitis prevention and management in primary health care. Member States requested for technical assistance from WHO to sustain essential immunization activities and to conduct background assessment for integrating the goals and pillars of the Roadmap into their national immunization strategies and epidemic preparedness and response plans. Actions already taken in the Region 67. All countries in the SE Asia Region have introduced the haemophilus influenzae type b (Hib) vaccine as part of the combined DTP–HepB–Hib vaccine regimen. Five countries (Bangladesh in 2015, Bhutan in 2019, India in 2021, Myanmar in 2016 and Nepal in 2015) have introduced the pneumococcus conjugate vaccine (PCV) nationwide. PCV has also been introduced in some provinces in Indonesia and Thailand. In several countries, the vaccine against meningococcus is offered to special populations such as travellers and pilgrims. SEA/RC75/15 Page 16 68. The Regional Office supports invasive bacterial disease (IBD) surveillance in six countries, which provides genotyping data needed to make decisions for the introduction of Hib, PCV and meningococcus vaccine and vaccine impact assessment, as well as useful data on antibiotic- sensitivity for effective and efficient case management. Actions to be taken in the Region 69. Priority countries are being supported to introduce or expand vaccine introductions and improve coverage. IBD surveillance will be expanded and strengthened. A baseline situational analysis will be conducted by WHO, followed by the preparation of a Regional Implementation Plan aligned with the Global Roadmap on defeating meningitis by 2030. SEA/RC75/15 Page 17 8) Standardization of nomenclature of medical devices Background 70. A standardized medical devices nomenclature (MDN) is essential for defining and naming innovative technologies, classifying medical devices for regulatory approval and streamlining procurement. Standardized naming of medical devices is required when describing devices needed for the health services-related benefits packages that are in place to provide universal health coverage to the people. A standardized international classification, coding and nomenclature for medical devices available to all Member States will support: • patient safety, • access to medical devices for universal health coverage, • emergency preparedness and response, and • efforts to increase quality of health care. 71. As of 1 June 2022, 75 Member States reported not using any particular MDN, 15 Member States used more than one MDN system (by different agencies of government and industry) and 32 Member States used a nationally developed MDN. The Member States in the South-East Asia Region have expressed the need for a standardized MDN. A standardized MDN is essential for improving access to medical products, which will support attainment of the Triple Billion targets. 72. Prior to the Seventy-fifth World Health Assembly, several informal consultations and behind-the-scenes meetings had been conducted to achieve consensus on the proposed text of the draft resolution on “Standardization of Medical Devices Nomenclature”. Several Member States with well-established medical devices development ecosystems opposed WHO’s initiative to proceed with MDN standardization, on account of concerns that this would unfavourably impact their investments made in the private MDN systems that they use (one such case in point is GMDN, the Global Medical Device Nomenclature). 73. Other Member States, both with and without well-established medical device ecosystems, emphasized that the standardized MDN must be of a non-commercial nature, as a public good solely within WHO’s control, similar to the processes involving the International Classification of Diseases (ICD). Many other Member States, especially lower-income countries and those with smaller populations, expressed an urgent need for MDN and requested that work on this proceed without delay. SEA/RC75/15 Page 18 Main operative paragraph and implications on the collaborative activities with Member States 74. The operative paragraph of the decision is “to integrate available information related to medical devices, including terms, codes and definitions, in the web-based database and clearinghouse established in line with resolution WHA60.29 of 2007 and now available as the Medical Devices Information System (MEDEVIS);5 and to link this to other WHO platforms, such as the International Classification of Diseases (ICD-11)6 to serve as a reference for stakeholders and Member States.” Actions already taken in the Region 75. Member States of the SE Asia Region were briefed in advance of the Seventy-fifth World Health Assembly about the proposed resolution and ongoing discussions held at the informal consultations and behind-the-scenes meetings. Three Member States (India, Indonesia and Maldives) delivered statements during the discussions held at the Seventy-fifth World Health Assembly. Actions to be taken in the Region 76. Work on MDN is being conducted at WHO headquarters and the results will be available on the WHO platforms identified as above. For countries already using a particular MDN, they have no problem continuing with it. For countries using more than one, there is a flowchart to help guide the various agencies to determine one MDN. For countries without a nomenclature, it is recommended that they can use the free and publicly available system, European Medical Device Nomenclature (EMDN). Technical assistance will be provided to any Member State requesting assistance in selecting a standardized medical devices nomenclature. 5 MeDevIS . Geneva: World Health Organization. https://medevis.who-healthtechnologies.org/ – accessed 1 Aug 2022. 6 International Statistical Classification of Diseases and Related Health Problems (ICD): ICD 11. Geneva: World Health Organization, 2022. https://www.who.int/standards/classifications/classification-of-diseases – accessed 1 Aug 2022. SEA/RC75/15 Page 19 9) Outcome of the Special Session of the World Health Assembly to consider developing a WHO convention, agreement or other international instrument on pandemic preparedness and response Background 77. Based on the experience of the COVID-19 pandemic, Member States identified various key issues that go beyond the International Health Regulations and other available mechanisms. These key issues were placed under the streams of Equity, Systems & Tools, Financing and Governance. 78. Based on the recommendations of various reviews and deliberations and the report of the Member States’ Working Group on strengthening WHO preparedness and response to health emergencies (WGPR), a Special Session of the World Health Assembly was held from 29 November to 1 December 2021 to consider developing a WHO convention, agreement or other international instrument on pandemic preparedness and response. Main operative paragraph and implications on the collaborative activities with Member States 79. This second-ever Special Session of the World Health Assembly in end-2021 decided: a) to establish, in accordance with Rule 41 of its Rules of Procedure, an intergovernmental negotiating body open to all Member States and Associate Members (or the “INB”) to draft and negotiate a WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response, with a view to adoption under Article 19, or under other relevant provisions, of the WHO Constitution as may be deemed appropriate by the INB; b) that the first meeting of the INB shall be held no later than 1 March 2022, in order to elect two Co-Chairs, reflecting a balance of developed and developing countries, and four Vice-Chairs, one from each of the six WHO regions, and to define and agree on its working methods and timelines, consistent with this decision and based on the principles of inclusiveness, transparency, efficiency, Member State leadership and consensus; c) that as part of its working methods, the INB shall determine an inclusive Member State- led process, to be facilitated by the Co-Chairs and Vice-Chairs, to first identify the substantive elements of the instrument and then begin the development of a working draft to be presented, on the basis of progress achieved, for the consideration of the INB at its second meeting to be held no later than 1 August 2022, at the end of which the INB will identify the provision of the WHO Constitution under which the instrument should be adopted in line with paragraph (a) of this section; SEA/RC75/15 Page 20 d) that the process referred to in paragraph (c) should be informed by evidence and should take into account the discussions and outcomes of the Member States’ Working Group on strengthening WHO preparedness and response to health emergencies, considering the need for coherence and complementarity between the process of developing the new instrument and the ongoing work under resolution WHA74.7, and particularly with regard to implementation and strengthening of the IHR (2005), which will be further discussed by the Member States’ Working Group on Amendments to the International Health Regulations (2005); and e) that the INB shall submit a progress report to the Seventy-sixth World Health Assembly in 2023 and present its outcomes for consideration by the Seventy-seventh World Health Assembly in 2024. 80. The INB started its work and identified substantive elements through discussions with and surveys of Member States and stakeholders through its digital platform. Public hearings were held in mid-April and the last meeting of INB was held during 15–17 June 2022. Actions already taken in the Region 81. Dr Viroj Tangcharoensathien from Thailand has been nominated by the Region as the Vice- Chair of the INB. 82. Nine out of 10 invited Member States from the SE Asia Region responded on the INB digital platform. Member States also regularly participated in the INB meetings and discussions. 83. The Regional Office for South-East Asia regularly shares technical updates, draft reports and other details on the INB discussions with Member States. Actions to be taken in the Region 84. The Secretariat will continue to facilitate and support Member States on the following: • written suggestions and inputs by Member States and relevant stakeholders, to be submitted through email; • participation in the Bureau Meeting(s) to develop a working draft, based on all the inputs provided; and • finalize the English version of the working draft for distribution to Member States by 1 July 2022, to be followed by translated versions. 85. The Second Meeting of the INB will be held on 18–22 July 2022 for consideration of the working draft on the basis of progress achieved and identification of the provision of the WHO Constitution under which the instrument should be adopted. SEA/RC75/15 Page 21 10) Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination Background 86. Well-designed and well-implemented clinical trials are indispensable for assessing the safety and efficacy of health interventions and informing associated comparative cost–effectiveness evaluations vis-à-vis existing interventions. Clinical trials on new health interventions are likely to produce the clearest results when carried out in diverse settings, including all major population groups the intervention is intended to benefit, with a particular focus on under-represented populations. Main operative paragraph and implications on the collaborative activities with Member States 87. The Seventy-fifth World Health Assembly held in May 2022 adopted the resolution WHA75.87 on “Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination”, which calls on Member States, in accordance with their national legal and regulatory frameworks and contexts, to prioritize the development and strengthening of national clinical trial capabilities and bolster clinical trial policy frameworks, particularly in developing countries. Actions already taken in the Region 88. The WHO Regional Office for South-East Asia has been assisting the SE Asia Region Member States in research prioritization and also in generation of timely and relevant research evidence by supporting public health research including well-designed and well-implemented clinical trials. It has been contributing to strengthening the overall research ecosystem by providing support for research governance, research ethics and research prioritization. During the COVID-19 pandemic, the WHO Regional Office has contributed to the WHO COVID-19 Solidarity therapeutics trial as part of the WHO-led global clinical trials to generate best evidence on treatment of the virus. Actions to be taken in the Region 89. The WHO Regional Office will participate in the stakeholders’ consultations to identify best practices and other measures to strengthen the global clinical trial ecosystem. It will also review the existing legal and policy frameworks, infrastructure, guidance and initiatives available in its Member States. It will provide guidance to Member States, on their request and taking into account national contexts, for developing legislation, infrastructure and capabilities required for clinical trials, including the implementation of the guidelines of the International Conference on Harmonization of Good Clinical Practices and of the registration of clinical trials in a publicly accessible database (once approved), in accordance with the WHO International Clinical Trials Registry Platform. 7 Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination. Doc. No. WHA75.8. Geneva: World Health Organization, 2022. https://apps.who.int/gb/ebwha/pdf_files/WHA75/A75_R8-en.pdf – accessed 24 June 2022 SEA/RC75/15 Page 22 11) Implementation of the International Health Regulations (2005) Background 90. The report on the implementation of the IHR by the Director-General to the Seventy-fifth World Health Assembly was submitted in response to resolution WHA61.2 of 2008, and to Decision WHA71(15) of 2018, calling for a report on the progress in implementation of IHR (2005) and the Global Strategic Plan to improve public health preparedness and response. With consideration for the proposal on IHR amendments, the Seventy-fifth World Health Assembly adopted the resolution WHA75.128 on “Amendment to the International Health Regulations (2005)”. Main operative paragraph and implications on the collaborative activities with Member States 91. The meetings of the IHR Emergency Committees on polio and COVID-19 were conducted periodically, and both maintained the status of a public health emergency of international concern and issued revised temporary recommendations. The Review Committee on the Functioning of the IHR (2005) conducted its work until April 2021 and produced a report with 40 recommendations. Two State Parties submitted the proposed amendments to the Regulations for consideration by the Seventy-fifth World Health Assembly, which agreed to establish a Working Group on Amendments to the International Health Regulations (2005) (WRIHR) to review it as well as other such proposals. 92. The Secretariat continued to provide technical support for strengthening national IHR capacities related to event management, laboratory, risk communication and information about compliance over several requirements of the Regulations, including additional health measures, event notification and verification, points of entry and yellow fever vaccination. 93. The majority of the Member States endorsed the proposal for amendments of the IHR (2005), which could be limited in scope and targeted towards maintaining the main architecture of the IHR. The Seventy-fifth World Health Assembly adopted the amendments to Article 59, and the consequent necessary updates to Articles 55, 61, 62, and 63, of the International Health Regulations (2005). The main implication was that amendments to these Regulations shall enter into force 12 months after the date of notification under Article 59 instead of 18 months as before. Actions already taken in the Region 94. Actions already taken in the Region include: • Member States’ have maintained active involvement in the IHR Monitoring and Evaluation Framework (MEF) including 100% compliance with SPAR. 8 Amendments to the International Health Regulations (2005). Doc. No. WHA75.12. Geneva: World Health Organization, 2022. https://apps.who.int/gb/ebwha/pdf_files/WHA75/A75_R12-en.pdf – accessed 27 June 2022 SEA/RC75/15 Page 23 • IHR capacity strengthening activities have been implemented along the provisions of the Delhi Declaration in 2019. • Regional meetings on strengthening implementation of the Risk Communication Strategy for public health emergencies, specifically focusing on risk communication and community engagement (RCCE) and on the lessons learnt from the COVID-19 response, were held in August and October 2021 respectively. • PoE assessments were conducted in Bangladesh, Bhutan, India and Nepal in 2021. • Piloting of the Universal Health and Preparedness Review (UHPR) in Thailand was completed on 21–29 April 2022. • The Regional meeting on the “South-East Asia Regional Roadmap for diagnostic preparedness, integrated laboratory networking and genomic surveillance (2023–2027)” was held virtually on 28–29 June 2022. MoH representatives of all Member States except Myanmar and DPR Korea participated in the meeting. In addition, relevant colleagues from WHO country offices, various key international development partners and select experts who were invited also participated, with the number of attendees numbering about 90. The meeting discussed the draft roadmap and provided feedback and suggestions for its finalization. The advanced draft incorporating feedback was presented to and considered by the distinguished delegates at the HLP Meeting. Based on the discussions and recommendations made by the HLP Meeting, the final Roadmap will be presented to the Seventy-fifth Session of the Regional Committee for its consideration and adoption. • The Meeting on the “Regional Strategic Roadmap on Health Security and Health System Resilience for Emergencies 2023–2027” was held in hybrid mode from 29 June to 1 July 2022. MoH representatives from all Member States except Myanmar and DPR Korea, numbering more than 100, participated in the meeting. In addition, relevant colleagues from the departments of Health Emergencies, Health Systems Development and Communicable Diseases at the Regional Office and from country offices, key colleagues from WHO headquarters and key international development partners, as well as invited experts, joined the meeting. They deliberated on the draft Roadmap presented and provided feedback and suggestions for its finalization. The advanced draft incorporating all feedback and comments was presented at the HLP Meeting. Recommendations made by the HLP Meeting were incorporated in the final Roadmap that will be presented to the Seventy-fifth Session of the Regional Committee for its consideration and adoption. Actions to be taken in the Region 95. The following actions are to be taken in the Region: • A regional IHR monitoring and evaluation meeting is due to be held. • The National Rapid Response Teams Learning Programme is scheduled tentatively to be held in Nepal. SEA/RC75/15 Page 24 • PoE assessments in Indonesia and Timor-Leste have to be completed. • A regional risk communication meeting to discuss the challenges of mis-information and the infodemic and also develop a regional plan on combating misinformation is also due to be held. • Regional contributions to various committees and working groups related to IHR (2005) and the new instrument on pandemic preparedness and response are being provided. SEA/RC75/15 Page 25 12) Influenza preparedness Background 96. The Seventy-third World Health Assembly in 2020 vide Decision WHA73(14) released the WHO Global Influenza Strategy 2019–2030.9 It promotes coordinated synergies between influenza preparedness and response capacity-building, the provisions of the International Health Regulations (2005) and immunization programmes. Implementation of the Strategy will enable the achievement of two high-level outcomes: better global tools and stronger country capacities. 97. The Global Influenza Strategy aims to approach influenza preparedness holistically through the establishment of new and strengthening of existing capacities to prevent, control and prepare for influenza at the global, regional and national levels. To do that it has two outcomes: Outcome one – better global tools for the prevention, detection, control and treatment of influenza; Outcome two – stronger country capacities such that every country has an evidence-based influenza programme that meets national needs and is integrated within the efforts to achieve health security and universal health coverage. Main operative paragraph and implications on the collaborative activities with Member States 98. As mandated by the Strategy, countries are supported to establish national seasonal influenza prevention and control programmes for building stronger country capacities. WHO together with partner agencies under the Global Influenza Surveillance and Response System (GISRS) is developing better global tools for universal use. The Pandemic Influenza Preparedness (PIP) Framework acts as the key guidance parameter for pandemic influenza preparedness and response in the Region. WHO uses a standard criterion to prioritize countries for receiving PIP Partnership Contribution (PC) funds. The “most critical” seven Member States in the SE Asia Region – the most vulnerable countries that need more support for development of PIP capacities relative to the other four Member States – are additionally supported by WHO through targeted PIP partnership contribution funds. This is to ensure capacity enhancement for pandemic influenza preparedness in these seven countries. 99. WHO collaborates with Member States in promoting a holistic approach to prevention and control, preparedness and response to influenza epidemics and pandemics through the national programmes. Rapid sharing of influenza viruses of pandemic potential is a major aspect of this collaboration. In this regard, WHO as the Secretariat needs to work on potential solutions to address systemic problems of access to benefits-sharing. Another aspect is technical collaboration for establishing sustainable surveillance for respiratory viruses of pandemic potential including demands of better diagnostics. 9 Global Influenza Strategy 2019–2030. Geneva: World Health Organization, 2019. https://apps.who.int/iris/bitstream/handle/10665/311184/9789241515320-eng.pdf?sequence=18&isAllowed=y – accessed 27 June 2022 SEA/RC75/15 Page 26 100. The Nagoya Protocol provides normative tools to promote efficient and equitable international access and benefit-sharing arrangements for pathogens. However, the next steps for addressing public health implications of the Nagoya Protocol (including opportunities to advance both public health and the principle of equitable sharing of benefits) by Member States and WHO as the Secretariat are critical for advancement of public health and improving harmonization between the Nagoya Protocol and existing pathogen-sharing systems in countries. 101. The current regional association in the field of genomic sequencing can easily be applied to influenza within the proposed Regional Strategy on genomic surveillance and sequencing in the SE Asia Region. This Regional Strategy is based on the Global Strategy, and a consultation among regional Member States prior to its finalization was held on 26–28 April. Influenza vaccines are the best interventions. Yet the collaborative association with Member States requires to look at widespread use of this tool at least for selected target groups with WHO regularly looking into needs of regional production, supply and distribution systems. Actions already taken in the Region 102. The following actions have already been taken in the Region: a. WHO’s South-East Asia and Western Pacific regions have been organizing an annual bi- regional meeting of Influenza Surveillance and National Influenza Centres with participation of Member States, WHO collaborating centres and partners. WHO has used this as a bi-regional platform for establishment and sustenance of policy guidance and strategic directions for influenza control, prevention and pandemic preparedness in the two WHO regions. b. A Regional Consultation with Member States on sustainable integrated surveillance for respiratory viruses of pandemic potential has been held virtually in New Delhi, India, in April 2022, for feeding into the global guidance (finalized during a consultation held in Geneva in May 2022). c. Technical guidance and support has been provided to establish and strengthen the national influenza programmes in all Member States. It has been ensured that these national influenza programmes of Member States have joined the Global Influenza Surveillance and Response System (GISRS). d. Technical support has been provided for implementation of the PIP Framework and Influenza Global Strategy under WHO’s Country Support Plan and the Thirteenth General Programme of Work. e. Member States have been provided sustainable funding support through PIP partnership contribution funds (the most critical seven countries as mentioned earlier in this section) and WHO’s funds including through the Regional Office’s Cooperative Agreement with the United States Centers for Disease Prevention and Control (US CDC). f. Facilitation, coordination and monitoring of virus-sharing with WHO collaborating centres has been ongoing. g. Technical assistance has been provided for national influenza pandemic preparedness planning based on lessons learnt from the COVID-19 pandemic, either as a standalone influenza pandemic preparedness plan in countries or as a contingency plan under the National Action Plan for Health Security (NAPHS). SEA/RC75/15 Page 27 Actions to be taken in the Region 103. The following actions are planned to be taken in the Region: a. Continuation of the annual bi-regional platform (with the Western Pacific Region) for Member States, WHO collaborating centres and partners for shaping the dynamic policy and strategic changes needed in the Asia-Pacific. b. WHO plans to support Member States on a systematic approach to plan for mitigating the public health impact of the implications of the Nagoya Protocol in the countries. c. Support for virus-sharing by Member States in the Region with the GISRS will continue by addressing systemic issues faced by countries. In this regard, the Regional Office intends to request WHO headquarters to include Member States of the Region in the proposed consultation to be conducted by the WHO Working Group on virus-sharing. This will enable Member States to understand systemic issues related to virus-sharing and access to benefits and consider them in the recommendations document that they plan to submit to the PIP Advisory Group. d. Technical support will be provided to Member States to roll out the forthcoming WHO guidance on sustainable integrated surveillance for respiratory viruses of pandemic potential. SEA/RC75/15 Page 28 13) Global Health for Peace Initiative Background 104. Peace has been an integral part of WHO’s work, and the Constitution of WHO states that “the health of all peoples is fundamental to the attainment of peace and security”. In 1986, the Ottawa Charter for Health Promotion listed peace as the first of a list of prerequisites for health. In 1997, WHO created the “Health as a Bridge for Peace” Programme to link health interventions with peacebuilding in conflict-affected settings. 105. Following recent changes at the global policy level such as the twin 2016 resolutions on “Sustaining the Peace Agenda” of the United Nations (passed by the UN Security Council and General Assembly) and the Global Strategic Direction of the Humanitarian-Peace Nexus or “Triple Nexus”, all UN agencies including WHO are expected to maximize their contributions to peace within their agendas while working towards collective outcomes agreed upon by all stakeholders in humanitarian, development and peacebuilding activities. 106. With the launch of Global Health for Peace Initiative (GHPI) in November 2019, WHO has renewed and advanced its efforts to position the health sector and itself as an influencer to achieve peace. This initiative aims to adopt health interventions that are conflict-sensitive and deliver peace dividends in conflict-affected and fragile settings. Main operative paragraph and implications on the collaborative activities with Member States 107. During the Seventy-fifth World Health Assembly in May 2022, Member States welcomed the report on the Global Health for Peace Initiative and expressed appreciation of the progress made in advancing health for peace activities. Member States also requested WHO to develop a roadmap for implementation of GHPI and build capacities of Member States to adopt conflict- sensitive health interventions that deliver peace dividends. Further, Member States opined that to implement the GHPI’s activities, it is critical for WHO to secure adequate financial resources, strengthen partnerships and enhance advocacy. 108. Thailand considered the link between health and peace as very important and has since long been an advocate for a comprehensive report on peace-building and health. Thailand has also offered to contribute actively in developing a roadmap for GHPI implementation and engaging constructively with WHO on this. 109. Indonesia recognized the importance of Global Health for Peace Initiative and supported its adoption by the WHO Executive Board. Indonesia also highlighted the need for further discussion in developing a roadmap for implementation on GHPI. 110. Member States also acknowledged that for GHPI to be successful, a collective action is required to align national, regional and global efforts by all partners in health sectors. Member States agreed that the “Health for Peace” approach is not only relevant to fragile, conflict-affected and vulnerable settings (countries impacted by emergency and insecurities) but is equally relevant for all countries as the health and well-being of all people is fundamental to the attainment of peace and security worldwide. The Region too stands to benefit from GHPI. SEA/RC75/15 Page 29 Actions already taken in the Region 111. The Regional Office for South-East Asia has been supporting the GHPI roll-out through dissemination of technical briefs to Member States of the Region and engaging with countries to support peace-building approaches that are already ongoing. Actions to be taken in the Region 112. The following actions are proposed to be taken in the Region: a. A roadmap for the implementation of GHPI along with a practical guide on health for peace are being developed. b. Support to Member States in mainstreaming peace-building approaches in health programmes that will be critical in achieving the Triple Billion targets continues. c. Financial resources to implement GHPI activities must be secured. d. Focus on building and strengthening capacities of Member States to progress in delivering on objectives of the Health for Peace Initiative is reaffirmed. SEA/RC75/15 Page 30 14) Polio transition planning and polio post-certification Background 113. The Director-General’s report to the Seventy-fifth World Health Assembly provided an update on the implementation of the Strategic Action Plan on Polio Transition 2018–2023 within the context of the COVID-19 pandemic. The report highlighted that the focus of polio transition efforts were at the country level with emphasis on integration and sustainability. 114. A mid-term evaluation of the Strategic Action Plan was conducted by an external independent evaluation team. An executive summary of the evaluation report was submitted to the Seventy-fifth World Health Assembly. 115. The fifth report of the Polio Transition Independent Monitoring Board (TIMB) focused on increasing interdependence between eradication and transition, making recommendations for actions by programmes to move forward the eradication and transition agendas. 116. The South-East Asia Region has a single integrated network for surveillance and immunization that provides support not only for polio eradication, but also for measles and rubella elimination, surveillance for vaccine-preventable diseases, strengthening immunization and responding to emergencies. The integrated network makes the Region most advanced among WHO regions for polio transition. Main operative paragraph and implications on the collaborative activities with Member States 117. Actions in the Region will be drawn noting that the Seventy-fifth World Health Assembly has: a. reaffirmed commitment to integrate polio assets into national health systems to strengthen broad disease surveillance, outbreak response capacities and immunization services; b. urged Member States to ensure that domestic resources are available to finance the Polio Eradication Strategy (2022–2026) of the Global Polio Eradication Initiative (GPEI), including response to emergencies/pandemics including polio; c. appreciated the role of polio infrastructure in COVID-19 response that was a demonstration of the capacities that can be achieved when programmes are used in an integrated way focused on the right to health and where there is the necessary political will, and noted that it is also an example of the possibilities that will emerge once we eradicate polio and complete the transition; and d. noted the recommendations of the mid-term evaluation of the implementation of the Strategic Action Plan on Polio Transition 2018–2023 and urged WHO that these be addressed as a priority. SEA/RC75/15 Page 31 Actions already taken in the Region 118. All five countries in the Region prioritized for polio transition (Bangladesh, India, Indonesia, Myanmar and Nepal) have developed their national transition plans adopting a country-centric approach and steps are being taken towards financial sustainability. 119. The Regional Steering Committee for Polio Transition (formed in 2019) continues to provide oversight to the transition process. 120. A regional publication ‘NeXtwork’ was developed in 2021 to comprehensively document the role of integrated surveillance and immunization infrastructure in COVID-19 response. 121. Polio transition and post-certification continue to be placed as Agenda items in key regional meetings. Actions to be taken in the Region 122. Broadening the scrutiny of national transition plans, as recommended in the fifth report of the Polio Transition Independent Monitoring Board (TIMB), is necessary. 123. The Regional Action Plan on Polio Transition needs to be developed by the end of 2023, as recommended in the mid-term evaluation report. SEA/RC75/15 Page 32 15) WHO Implementation Framework for the Billion 3 – Outcome of the SIDS Summit for Health: For a healthy and resilient future in small island developing states Background 124. Climate change threatens the health of the people of all Member States, but the populations of small island developing states (SIDS) are among the first and hardest hit and most vulnerable. SIDS share grave health and sustainable development challenges posed by the impact of natural and man-made hazards, environmental degradation and rising sea levels due to global warming, health emergencies, loss of biodiversity and the effects of the COVID-19 pandemic. Recognizing that SIDS are disproportionately impacted by climate change, which undermines the progress towards their achievement of the 2030 Agenda for Sustainable Development, including Sustainable Development Goal 3 on health and well-being, the Seventy-fifth World Health Assembly adopted resolution WHA75.1810 titled “Outcome of the SIDS Summit for Health: For a healthy and resilient future in small island developing states”. 125. The resolution called for the Secretariat to continue to pursue the commitments made before and at the SIDS Summit for Health, which was held virtually on 28–29 June 2021, and requested for: a. support to establish a SIDS Leaders’ Group for Health for high-level advocacy and to drive further attention globally to the health challenges and initiatives of SIDS with collaboration across Member States and partners to better support the mechanism to address urgent health challenges of such states; and b. a report to be presented to the Seventy-seventh World Health Assembly in 2024 on the progress made in implementing this resolution as well as the outcomes of the second SIDS Summit for Health due to be held in 2023. Main operative paragraph and implications on the collaborative activities with Member States 126. There are two nations classified as SIDS in the SE Asia Region, Maldives and Timor-Leste. Both have their country plans and activities prioritized to their needs and receive continued technical support from WHO. Though there is no anticipation on any new implication on the collaborative activities or on the implementation of the actions and support outlined in the resolution, trained human resources remains a challenge in both countries. 10 Outcome of the SIDS Summit for Health: for a healthy and resilient future in small island developing states. Doc. No. WHA75.18. Geneva: World Health Organization, 2022. https://apps.who.int/gb/ebwha/pdf_files/WHA75/A75_R18-en.pdf – accessed 24 June 2022 SEA/RC75/15 Page 33 Actions already taken in the Region 127. Climate health profiles for both Maldives and Timor-Leste have been completed, health national adaptation plans developed and capacity-building on a vulnerability adaptation assessment through virtual training was provided in 2021. A Regional Plan of Action for SIDS in the African and South-East Asian Regions11 was developed in 2019. Actions to be taken in the Region 128. A “regional readiness proposal” is to be submitted to the Green Climate Fund in 2022 and both countries have been included in the project proposal. Technical support will be provided to both countries in the implementation of the Regional Plan of Action for SIDS in the African and South-East Asian Regions. 11 Climate change and health in small island developing states – Regional Plan of Action for SIDS in the African and South-East Asian Regions. World Health Organization, Regional Office for Africa and Regional Office for South-East Asia, 2019. http://apps.who.int/iris/handle/10665/312262?search- result=true&query=Climate+change+and+health+in+small+island+developing+States&scope=&rpp=10&sort_by=score&order =desc – assessed on 1 Aug 2022. SEA/RC75/15 Page 34 16) WHO Implementation Framework for Billion 3 – Well-being and health promotion Background 129. Health and well-being of the population is associated with peace, security, stability, economic growth and fair distribution of power and resources within and between countries. Social, economic and environmental conditions impact the health of societies, communities and people differently. Governments have direct responsibility for the health of their peoples, which can be adequately fulfilled only by the provision of adequate health and social measures. Promoting health and well-being requires environmentally and financially sustainable investment by multiple sectors within governments and contribution from wider society including social and economic actors among individuals, communities, NGOs and the private sector. 130. Promoting physical and mental health, social well-being, and Healthy life expectancy [https://www.who.int/data/gho/data/themes/topics/indicator-groups/indicator-group- details/GHO/life-expectancy-and-healthy-life-expectancy] for all is part of the UN General Assembly resolution (A/RES/70/1)12 titled “Transforming our world: the 2030 Agenda for Sustainable Development”. Multisectoral action on social, environmental and economic determinants of health for entire populations and specifically disadvantaged people in vulnerable settings is essential to create inclusive, equitable, economically productive and resilient healthy choices for individuals as well as healthy societies. Health promotion and protection and disease prevention requires responsive health systems with skilled, well trained and motivated workforces in adequate numbers with capacities to address broad public health measures and the determinants of health through policies across sectors, and the promotion of health literacy among the population. Main operative paragraph and implications on the collaborative activities with Member States 131. The Seventy-fifth World Health Assembly, considering the report by the Director-General, adopted resolution WHA75.1913 titled “Well-being and health promotion”. The resolution urges Member States to strengthen health promotion and disease prevention through high-impact public policies to address health determinants and reduce risk factors, including through appropriate regulation, and use health and equity impact assessments in their development. Responsive health systems will require the development of interventions at population, community and individual level to increase health literacy and improve capacity for health- informed decisions and health-seeking behaviours using innovative approaches, communication channels and technologies, and by the use of evidence guided by social and behavioural sciences. 12 Transforming our world: the 2030 Agenda for Sustainable Development. Doc. No. A/RES/70/1. New York: United Nations, 2015. https://www.un.org/en/development/desa/population/migration/generalassembly/docs/globalcompact/A_RES_70_1_E.pdf – accessed 1 Aug 2022 13 Well-being and health promotion. Doc. No. WHA75.19. Geneva: World Health Organization, 2022. https://apps.who.int/gb/ebwha/pdf_files/WHA75/A75_R19-en.pdf – accessed 1 Aug 2022 SEA/RC75/15 Page 35 132. Provision of continuous training on health promotion, disease prevention and health communication (including innovative technologies) is expected to strengthen health systems and empower the health workforce at all levels of health services ensuring that people in vulnerable situations have access to information. As appropriate, Member States are urged to consider establishing governmental, regional, subregional and local structures responsible for population- level health promotion, with sustainable financing and continuous reporting, and also strengthen population-based health promotion implementation and ensure resilience of the whole government/public structures. 133. Promoting health and well-being needs coordinated and multisectoral action throughout the life course addressing the conditions that affect people’s lives. Social participation and the empowerment of people in adopting important health decisions and assuming responsibility for their health and well-being will require actions from the public sector as well as good governance at all levels. Developing enabling environments conducive to health, particularly healthy, safe and resilient communities, makes it easier for individuals to make healthy choices. Actions already taken in the Region 134. All countries in the South-East Asia Region have taken steps to include basic health information and education in their curricula to ensure that health-care-related workers have appropriate levels of health literacy to implement quality and people-centred care and services throughout the life-course. The health workforce in preventive medicine- and community-based health services has been trained in health promotion, health education, disease prevention and health communication. Several countries have strengthened people-centred health services and endeavoured towards providing quality essential medicine and mental health services, vaccines, diagnostics and health technologies. At the same time, health promotion needs to go beyond health education, disease prevention and health communication. 135. The modicum of health promotion training varies widely among and between countries. Some Member States and institutions conduct training over limited sessions. Others may have credit courses lasting over a semester. The curriculum also varies across countries and institutions. Few health promotion officers in countries are fully trained and concrete estimates from ministries of health are not available. The curriculum also varies across countries and institutions. WHO has consistently urged Member States to give due importance to a robust training regimen. 136. Thailand has been leading in promoting health and well-being throughout the life-course and across sectors, with strong coordination between national and subnational government structures and whole-of-society approaches in response to the needs of people in vulnerable situations. The “health in all policies” approach is applied in addressing health and development, as well as in leading multisectoral actions addressing NCDs in Bhutan, Nepal, Sri Lanka and Thailand. Two SIDS countries, Maldives and Timor-Leste, developed national adaptation plans and capacity-building on vulnerability adaptation assessment to address climate change, as part of the response to the outcomes of the “SIDS Summit for Health: For a healthy and resilient future in small island developing states”. SEA/RC75/15 Page 36 137. Promoting health and well-being in the South-East Asia Region has been progressing in key healthy settings, namely workplaces, schools and cities/communities. The Seventy-fourth session of Regional Committee for South-East Asia adopted the resolution SEA/RC74/R314 on “Revitalizing the school health programme and health-promoting schools in the South-East Asia Region”. The resolution urged Member States to make every school a “health-promoting school” by 2030. The ministries of health and education in the South-East Asia Region have signed the Call for Action on the subject. 138. The Regional Directors of WHO, UNESCO, UNICEF, UNFPA and WFP released the Joint- Statement committed to promote health and well-being of students, teachers and staff in schools. Inclusive and transformative education for health and well-being was further endorsed by the Second Asia-Pacific Regional Education Minister’s Conference (APREMC II) in Bangkok on 5–7 June 2022. The Roadmap to support implementation of health-promoting schools has been developed in consultation with Member States. Maldives has scheduled a national conference for health-promoting schools in August 2022 which will further enhance health and well-being of students and teachers in the country while working across sectors. 139. The WHO Regional Office collaborated with Member States to strengthen effective actions on healthy cities through the regional laboratory on urban governance for health and well-being, ensuring that an enabling environment for health is accessible to all age groups and is responsive to people in vulnerable situations. Cities in Bangladesh, Bhutan, India, Indonesia, Maldives, Nepal, Sri Lanka and Thailand were engaged through multisectoral coordination and guidance for achieving healthier and fairer societies during COVID-19 and beyond were provided. This guidance was provided by WHO to train city officials in selected cities through a series of virtual meetings. Technical guidance and checklists of actions expected to be performed at the city level were provided. 140. A National Healthy City Network has been established in Indonesia. Commitments made and plan of actions for healthy cities have been initiated in Bhutan. Urban leadership and implementation of urban governance for health and well-being is progressing in Bangladesh. Draft framework for urban health equity and health interventions for cities initiatives in India are being pursued to address health of the urban poor, people with disabilities, age-friendly environment, and healthy settings within cities. Multisectoral partners have been invited to contribute to address the issues and design interventions suitable for their city contexts and a list of suggested interventions to achieve urban health equity has been prepared. Actions to be taken in the Region 141. The following actions are to be taken in the Region: a. Continuation of health promotion education for health workforces to be responsive to broader determinants of health (physical environment, social, cultural and economic determinants of health) and risk factors, and to be sensitive to people’s health literacy while developing generic disease prevention and health communication abilities. Currently many of the health messages are not necessarily corresponding to health literacy at the population level and thus behavioural changes are not being achieved. Health literacy is key to health promotion. 14 Revitalizing the school health programme and health-promoting schools in the South-East Asia Region. Doc. No. SEA/RC73/R3. New Delhi: World Health Organization, Regional Office for South-East Asia, 2021. https://apps.who.int/iris/bitstream/handle/10665/345269/sea-rc74-r3-eng.pdf?sequence=1&isAllowed=y – accessed 1 Aug 2022 SEA/RC75/15 Page 37 b. Strengthening the role of health promotion and enhancing capacities of health professionals to promote health and well-being throughout the life-course and particularly among people in vulnerable situations and engage with communities, local governments, and multiple sectors, where it is applicable, on a regular basis while ensuring that surge capacities are identified for emergency situations. c. Provision of adequate resources to orient public systems and infrastructures enabling health literacy, including understanding of health impacts and health equity, across sectors and particularly through healthy settings. d. Development of a framework on achieving well-being, building on the 2030 Agenda for Sustainable Development, and identifying the role that health promotion plays within this. e. Development of the implementation and monitoring plans of the Framework, and providing technical support to Member States in strengthening their governance, financing, human resources, evidence generation, data disaggregation and research structures, for overall well-being and health promotion of the population. f. Promotion and recommendation of scientifically sound interdisciplinary research to develop the evidence base for interventions for the promotion of health and well-being. SEA/RC75/15 Page 38 17) WHO Global Strategy for food safety Background 142. The Seventy-third World Health Assembly had endorsed resolution WHA73.5 titled ‘‘Strengthening efforts on food safety’’. Through the resolution, Member States requested the Director-General to update the WHO Global Strategy for food safety, which was finalized through a series of consultations with experts, Member States and partners. 143. The 150th session of the WHO Executive Board held in January 2022 considered the reports on the “WHO Global Strategy for food safety” (EB150/25) and “Reducing public health risks associated with the sale of live wild animals of mammalian species in traditional food markets – infection prevention and control” (EB150/26). The Board noted the reports and recommended two decisions for consideration of the World Health Assembly. 144. The Seventy-fifth World Health Assembly, vide its decision WHA75(22)15 adopted the updated WHO Global Strategy for food safety. The Assembly, vide its decision WHA75(23)16, recommended that an interim guidance on reducing public health risks associated with the sale of live wild animals of mammalian species in traditional food markets needs to be updated and supported with a country implementation plan. Main operative paragraph and implications on the collaborative activities with Member States 145. The choice of strategic priorities should be tailored to the respective country situation and Member States should modify, redesign or strengthen their national food safety systems as appropriate based upon the strategic priorities identified in the updated strategy. 146. There is a need to develop the country implementation roadmaps with availability of financial resources to support such work. Actions already taken in the Region 147. The National Food Safety Authorities in Member States of the WHO South-East Asia Region have been implementing the ‘Framework for Action on Food Safety in WHO South-East Asia Region (2020–2025)’, which will complement updated Global Strategy for food safety. 148. The Regional Framework for Action on Food Safety covers all aspects of the Global Strategy for food safety and major emphasis is given for strengthening national food control systems. 149. There is a tripartite coordination group in the Asia-Pacific Region and food safety is one of the priority areas for multisectoral collaboration. 15 WHO Global Strategy for food safety. Doc No. WHA75(22). Geneva: World Health Organization, 2022. https://apps.who.int/gb/ebwha/pdf_files/WHA75/A75(22)-en.pdf – accessed 1 Aug 2022 16 Reducing public health risks associated with the sale of live wild animals of mammalian species in traditional food markets – infection prevention and control. Doc No. WHA75(23). Geneva: World Health Organization, 2022. https://apps.who.int/gb/ebwha/pdf_files/WHA75/A75(23)-en.pdf – accessed 1 Aug 2022 SEA/RC75/15 Page 39 150. The Codex Trust Fund has supported Bhutan, India, Maldives, Nepal and Timor-Leste to strengthen Codex activities in these countries. 151. The WHO Regional Offices for South-East Asia and the Western Pacific have worked together and developed a manual on mitigating public health risks in traditional food markets. Actions to be taken in the Region 152. Member States will be supported to develop the country implementation plan for strengthening food safety in line with the Regional Framework for Action on Food Safety and the Global Strategy for food safety. 153. Considering the importance of traditional food markets in the Asia-Pacific Region, the WHO Regional Office for South-East Asia is supporting pilot projects on mitigating public health risks in selected Member States based on the WHO Manual for food safety. SEA/RC75/15 Page 40 18) Prevention of sexual exploitation, abuse and harassment Background 154. The Seventy-fifth World Health Assembly discussed the Director-General’s report on the Agenda item on “Prevention of sexual exploitation, abuse and harassment” (A75/29) along with the Report of the Programme Budget and Administration Committee (PBAC) of the WHO Executive Board to the Assembly on the Agenda (A75/50). Main operative paragraph and implications on the collaborative activities with Member States 155. The Member States of the SE Asia Region (in particular Bhutan, India, Indonesia and Thailand) and others expressed strong commitment to prevention of and response to sexual exploitation, abuse and harassment (PRSEAH) and acknowledged WHO’s comprehensive efforts thus far. Member States: a. reiterated their commitment to zero tolerance on sexual exploitation, abuse and harassment (SEAH); b. requested access to UN-wide ClearCheck screening database by Member States to prevent (re-)hiring of confirmed perpetrators; c. requested WHO to build a culture of reporting, investigation and timely action; d. requested coordination between WHO, partners and stakeholders, and updates on pending complaints and transparent sharing of information on new complaints; e. recognized the need to strengthen PRSEAH, especially in preparedness and response to health emergencies, scale up prevention, and strengthen health system capacities to safeguard victims; f. drew attention to the implications of SEAH on the achievement of the SDGs, especially SDG 5, and urged WHO to lead by example in the UN System. Actions already taken in the Region 156. The Regional Director accords high priority to PRSEAH in the SE Asia Region. Actions taken so far include at the Regional Office level: a. a PRSEAH Working Group has been established in the Region comprising members from technical departments in the Regional Office, select WHO country offices and the Staff Association; and b. creation of activity workplan in the WHO Planning Portal to allocate the funds received for implementation of the proposed activities – US$ 2.5 million from the United States Government’s COVID-19 grant and approximately US$ 250 000 from the assessed contributions. SEA/RC75/15 Page 41 157. The following actions have also been taken at the Country Office level: a. a briefing of all WHO Representatives held in March 2022; b. appointment of focal points on PRSEAH in each WHO country office; c. distribution of funds to country offices for supporting PRSEAH activities; d. finalization of the post-descriptions of dedicated full-time PRSEAH staff in select country offices in the Region (a P4 position in the Cox’s Bazar Office; NPOs in other select country offices) and draft terms of reference shared for consultant positions in other country offices; e. sharing of guidance, tools and resources on country-level implementation of PRSEAH; f. one-on-one planning/briefing meetings held to support workplan development and implementation; and g. orientation of staff in select country offices. 158. Other actions taken at the Regional Office level: a. orientation sessions have been held for over 200 staff from all departments; b. the global #NoExcuse Campaign was observed during Goals Week in 2022 with all staff mandated to include PRSEAH in the “Team objectives” section of their annual electronic appraisal mechanism (ePMDS); c. timely completion of the mandatory staff trainings has been achieved; d. an activity workplan in the WHO Planning portal has been created, a consultant has been hired, and timely implementation of the activities has been initiated; e. HR positions at P5 level at the Regional Office and P4 level at the Cox’s Bazar Field Office in Bangladesh have been included in the global roster with participation of the Regional Office in the selection process; and f. use of ClearCheck, an UN-wide database for screening candidates before recruitment and prevent the (re-)hiring of confirmed perpetrators across the UN System, has been initiated; g. a mission by the Department of Internal Oversight Services (IOS) of headquarters to the Regional Office in July 2022; and h. a Townhall meeting by the Regional Director, held on 25 July 2022, attended by the Regional and Country Office Staff. Actions to be taken in the Region 159. Other planned and ongoing activities in the Region include: a. a Regional Directors’ Summit or meeting of focal points of the regional UN country teams to strengthen alignment and collaboration among UN partners; b. tailoring of standard training and orientation packages to the regional context and roll- out of the same; SEA/RC75/15 Page 42 c. development of PRSEAH communication materials and its use to support planned activities; d. capacity enhancement of the WHO Country Office focal points, implementing partners and communities; and e. organization of a training of trainers’ workshop on strengthening the health sector response to gender-based violence. 160. At the country office level, planned activities include: a. development of country-specific risk assessment and mitigation plans; b. strengthening capacity and systems among implementing partners; and c. adaptation, translation and use of tailored training/orientation and communications materials. SEA/RC75/15 Page 43 19) Global Strategy and Plan of Action on public health, innovation and intellectual property Background 161. The Global Strategy and Plan of Action (GSPA) on public health, innovation and intellectual property provided several recommendations and progress indicators were developed to foster innovation and improve access to health products. Main operative paragraph and implications on the collaborative activities with Member States 162. In May 2022, the Seventy-fifth World Health Assembly, noting the consolidated report submitted by the WHO Director-General (WHA75/10 Rev.1) and considering the decision of the WHO Executive Board adopted at its 150th session in January 2022 (EB150(11)), adopted the resolution WHA75.1417 titled ‘Global Strategy and Plan of Action on public health, innovation and intellectual property’, thus extending the timeframe of the Global Plan of Action on public health, innovation and intellectual property from 2020 to 2030. Actions already taken in the Region 163. Many meetings have been held and actions taken for the implementation of the GSPA on public health, innovation and intellectual property in the Region. Meetings organized in the SE Asia Region in the previous five years are summarized in the table below: Table 1. Meetings held by Member States in the SE Asia Region on GSPA 1−14 December 2020 Current good manufacturing practices (cGMP) online workshop for pharmaceutical manufacturers in active pharmaceutical ingredients (API) and formulations for access to quality-assured medical products 28 August 2020 SEARN: Virtual regulatory brief on vaccine clinical trial solidarity protocol 7 May 2020 SEARN virtual meeting on regulatory updates on COVID-19 pandemic 19–21 November 2019, New Delhi, India World Conference on Access to Medical Products: Achieving the SDGs 2030 19–20 November 2019, Bangkok, Thailand International Trade and Health Conference 2019: ASEAN trade and health − seeking a common ground towards SDGs 23–25 April 2019, New Delhi, India Third Annual Meeting of South-East Asia Regulatory Network 17 Global strategy and plan of action on public health, innovation and intellectual property. Doc. No. WHA75.14. Geneva: World Health Organization, 2022. https://apps.who.int/gb/ebwha/pdf_files/WHA75/A75_R14-en.pdf – accessed 1 Aug 2022 SEA/RC75/15 Page 44 15–16 November 2018, Bangkok, Thailand International Trade and Health Conference 2018: Belt and Road Initiative − Opportunities and challenges for health 9–11 October 2018, New Delhi, India 2nd World Conference on Access to Medical Products: Achieving the SDGs 2030 21–23 March 2018, Colombo, Sri Lanka Second Annual Meeting of South-East Asia Regulatory Network 28–29 November 2017 Bangkok, Thailand International Trade and Health Conference 2017: Looking into the future, assessing the current situation 21–23 November 2017, New Delhi, India First World Conference on Access to Medical Products and International Laws on Trade and Health, in the context of the 2030 Agenda for Sustainable Development 11–12 April 2017, New Delhi, India First Annual Meeting of South-East Asia Regulatory Network 2016 and 2017 SE Asia Region Member States participated in the evaluation and programme review of GSPA 164. The International Trade and Health (ITH) Conference in Thailand, organized by the National Commission on International Trade and Health Studies (NCITHS) together with the International Trade and Health Programmes, on 24–26 November 2021, on “Future international trade and health: Post COVID-19 pandemic” explored the impact of COVID-19 on international trade and health aspects. The Conference developed new thinking on: • revisiting the international trade and health aspect of COVID-19; • making vaccines, medicines and diagnostics related to COVID-19 and other health emergencies global public goods; and • new global governance of international trade and health. 165. In addition, in 2021 and 2022, first-of-their-kind online workshops on current good manufacturing practices (cGMP) were organized and implemented by all three levels of WHO (country offices, Regional Office and headquarters) in collaboration with the Ministry of Health and Family Welfare, Government of India, and other partners. The cGMP online workshops also address COVID-19 challenges to access to medical products. These workshops are summarized in Table 2. SEA/RC75/15 Page 45 Table 2. Virtual Workshops on current good manufacturing practices (cGMP) for access to quality- assured medical products (medicines, vaccines, diagnostics and devices) WHO-JSS Mysuru – IPA Workshop Category Dates 2020–2021 Number of participating units Number of participants Duration (in days) Details on current Good Manufacturing Practices (cGMP) online workshops for pharmaceutical units is published on both South- East Asia Region and headquarters websites: 1. South-East Asia Region: https://www.who.int/so utheastasia/health- topics/universal-health- coverage 2. WHO HQ https://www.who.int/so utheastasia/news/detail/ 10-12-2021-current- good-manufacturing- practices-(cgmp)- online-workshops-for- pharmaceutical-units PiIot Formulation 1–14 December 33 101 12 1. Formulation 5–18 May 40 143 12 2. APls 24 May–5 June 35 139 12 3. APls 14–26 June 49 166 12 4. Medical devices 5–9 July 51 165 05 5. APls 19–30 July 115 310 12 Total 323 1115 Pilot Mentorship Programme August–December 2021 33 units Mentorship Programme All March–August 2022 In progress Actions to be taken in the Region 166. Activities under the GSPA must be continued and support to Member States in effective implementation of GSPA provided with interplay among public health, innovation and intellectual property sectors. SEA/RC75/15 Page 46 20) Traditional medicine Background 167. Given the importance of traditional medicine in the national health systems, World Health Assembly resolution WHA67.18 of 2014 urged Member States to adapt, adopt and implement the WHO Traditional Medicine Strategy 2014–2023, which has two goals: to harness the potential contribution of traditional medicine to health, wellness and people-centred health care, and to promote the safe and effective use of traditional medicine through appropriate regulation. The Strategy’s three objectives include building a knowledge base; strengthening quality assurance, safety and efficacy; and promoting UHC through integration. The Strategy tenure will end in the year 2023. 168. A steady progress is observed in the global implementation of the Strategy and resolution in terms of policy, regulation, national programmes, research, health insurance and integration across Member States. 169. Given the importance of traditional medicine in primary health care (PHC), a number of resolutions in this context have been adopted by the Member States. These include the 2018 Declaration of Astana on primary health care, UNGA Resolution 69/131(2014) on celebrating 21 June as International Day of Yoga, and UNGA Resolution 74/2(2019) on the integration of safe and evidence-based traditional medicine services within health systems, particularly at the primary health care level. 170. A memorandum of understanding (MoU) between the Ministry of Ayush, Government of India, and the World Health Organization, for setting up the WHO Global Centre for Traditional Medicine (WHO-GCTM) was signed on 25 March 2022. The groundbreaking ceremony in India was attended by the honourable Prime Minister of India, H.E. Mr Narendra Modi, and the WHO Director-General, Dr Tedros A. Ghebreyesus, on 19 April 2022 at Jamnagar in the state of Gujarat, India. 171. The Seventy-fifth World Health Assembly noted the Director-General’s report on the implementation of the WHO Traditional Medicine Strategy 2014–2023 and resolution WHA67.18 of 2014. A total of 19 Member States including four Member States from the SE Asia Region (Bhutan, India, Indonesia and Thailand) presented their interventions. The Assembly adopted Decision WHA75(19) requesting the Director-General to submit a final progress report to the Seventy-sixth World Health Assembly in May 2023 through the Executive Board at its 152nd Session in January 2023. Main operative paragraph and implications on the collaborative activities with Member States 172. Despite a steady progress in implementing the Global Strategy, Member States still face key challenges such as lack of research evidence and data, financial support and inadequate mechanisms to monitor and regulate traditional medicines practice, products and practitioners. SEA/RC75/15 Page 47 173. Member States have requested for policy and technical guidance and support from WHO on integration of traditional medicine into the health-care delivery system, traditional medicines research and evaluation, and regulatory framework, and on setting up a platform for information sharing on regulatory issues, capacity-building, research databases, and enhancing cross-sectoral coordination and collaboration for sustainable development of traditional medicines. Actions already taken in the Region 174. The Regional Action Plan with four priority areas: (1) system performance monitoring; (2) safety monitoring for traditional medicines products; (3) research capacity-building; and (4) integration of traditional medicines into the health-care delivery system, was developed in October 2015. 175. The following actions have been taken under the four priority areas: a) development of standard core and reference indicators and their metadata; b) development of a web-based data collection tool and dashboard for monitoring performance of the traditional medicine system; c) conduct of several regional training workshops on pharmacovigilance for safety monitoring of traditional medicines; d) collation of case studies from several countries on pharmacovigilance for traditional medicines; e) conduct of a regional hands-on training on laboratory-based quality control activities on traditional/herbal products in the year 2022; f) conduct of a regional workshop on research methodologies for traditional medicine, and development of research methodologies; g) conduct of several country case studies on traditional medicine research including research projects in the context of COVID-19; h) conduct of a regional workshop on appropriate integration of traditional medicine into the national health system and review on progress in traditional medicines for 2014– 2019; and i) publication of a regional compendium titled “Traditional medicine in the WHO South- East Asia Region: review of progress 2014–2019” in 2021. Actions to be taken in the Region 176. The current priority areas remain relevant to the Region. The Regional Office for South-East Asia will take advantage of the establishment of the WHO-GCTM in Jamnagar, India, to amplify regional efforts on traditional medicine research capacity-building and evidence synthesis for people’s health. 177. The Regional Office will also continue to provide policy and technical guidance and support to Member States through implementation of the WHO Strategy and learn from and build on the progress achieved, specifically in traditional medicines research, regulation and integration into health systems, towards achieving universal health coverage, the Triple Billion targets of the GPW13 and the SDGs. SEA/RC75/15 Page 48 21) Public health dimension of the world drug problem Background 178. As per the World Drug Report 2021, around 275 million people reportedly used psychoactive drugs during the year 2020 [World drug report 2021, United Nations Office on Drugs and Crime (UNODC)]. This is expected to rise by 11% worldwide and 40% in Africa alone by the year 2030. With an estimated 36 million people living with drug use disorders globally, the scope of global public health problems related to drug use, drug use disorders and associated health conditions continues to be very high. 179. In 2017, The Seventieth World Health Assembly adopted decision WHA70(18), among others, to recognize the need for intensified efforts in addressing and countering the world drug problem. A public health approach is widely recognized as essential to addressing the global drug problem at all levels. 180. Effective progress towards the achievement of target 3.5 and other health-related targets of the Sustainable Development Goals requires enhanced and sustained WHO actions aimed at promoting and supporting prevention, early identification and effective management of substance use disorders; improving access to controlled medicines; reducing the burden of drug-related infectious diseases and prevention of the harms associated with drug use; effective monitoring of the health consequences of drug use, as well as public health policy and programme responses; and promoting a public health approach to the global drug problem. 181. The Seventy-fifth World Health Assembly, having considered the report of the Director- General and vide Decision WHA75(20),18 decided to request the Director-General to continue to report to the Health Assembly every two years until 2030 on WHO’s activities to address the public health dimensions of the world drug problem and progress made in the implementation of Decision WHA70(18) of 2017. Main operative paragraph and implications on the collaborative activities with Member States 182. Regions highlighted their concern with the increase in the number of people using psychoactive drugs and their effect on communities. 183. Member States acknowledged WHO’s collaboration with the United Nations Office on Drugs and Crime (UNODC) and the International Narcotics Control Board. WHO has expanded the scope of collaboration with UNODC further to include the prevention, detection and response to substandard and falsified medical products at the global level, which is another area of collaborative work between WHO and UNODC. 184. The COVID-19 pandemic has had a significant impact on the provision of health services for substance use disorders, as evidenced by the results of the WHO rapid assessment in 2020 of the impact of COVID-19 on mental, neurological and substance use services. 18 Public health dimension of the world drug problem. Doc. No. WHA75(20). Geneva: World Health Organization, 2022. https://apps.who.int/gb/ebwha/pdf_files/WHA75/A75(20)-en.pdf – accessed 1 Aug 2022 SEA/RC75/15 Page 49 185. Member States expressed concern at the low access to medication for moderate and severe pain, particularly in low- and middle-income countries, and recognized that the need for access to pain relief must be viewed in the context of concerns about the harm arising from the misuse of select medications, including opioids. 186. Member States in the SE Asia Region highlighted the continued lack of access to opioid treatment in the Region and called on the Secretariat to support access to opioid medicines. Punitive measures and aggressive laws still inhibit access to opioid therapy. 187. There is need for bolstering the training of health-care workers on the use of opioids to reduce stigma. Essential opioid medicines are still not included in the essential medicines lists (EML) of a number of countries. 188. Maldives presented a Regional One Voice statement and supported the recommendations presented by the WHO Expert Committee on drug dependence under the Commission on Narcotic Drugs as well as the interagency work being facilitated by WHO. Actions already taken in the Region 189. The Region is committed to enabling access to essential opioids in Member States. A standardized assessment was conducted last year on the status of policies and programmes in the 11 countries. This led to structured documentation of barriers and enablers in implementation. Most countries in the Region have limited access to essential opioids necessary for moderate to severe pain relief mostly due to heavy regulations over their access. Actions to be taken in the Region 190. Continued support will be provided to Member States for enabling access to essential opioids in the Region. A regional publication on the situation in countries with regard to access to opioids is currently being produced. SEA/RC75/15 Page 50 22) Standing Committee on Health Emergency (Pandemic) Prevention, Preparedness and Response Background 191. The work of WHO in health emergencies has expanded considerably over the last two decades, as reflected under one of the four pillars of the Thirteenth General Programme of Work (GPW13). This expansion has increased the demands on the Governing Bodies, leading to concerns that Member States do not have adequate opportunities to address the work of the Organization in this key area. 192. Member States agreed to establish a Standing Committee on Health Emergency (Pandemic) Prevention, Preparedness and Response, as a sub-committee of the Executive Board. Accordingly, the WHO Executive Board, at its 151st session held in May 2022, adopted Decision EB151(2)19 to establish such a committee with agreed terms of reference. Main operative paragraph and implications on the collaborative activities with Member States 193. The key terms of reference of the Standing Committee, as agreed by the WHO Executive Board, include: a. Composition of the Standing Committee: i. The Committee shall comprise 14 members, two from each Region, selected from among members of the WHO Executive Board, reflecting a balanced representation of developed and developing countries, as well as the Chair and the Vice-Chair of the Executive Board, who will be ex-officio members. Members of the Standing Committee shall serve for a term of two years. ii. There shall be two Officebearers: a Chairperson and a Vice-Chairperson, who shall be appointed from among the Committee members, and shall serve for a one-year term. The committee may invite observers and experts, as appropriate. b. Functions: i. In the event of a public health emergency of international concern (PHEIC), provide guidance to the Executive Board and advice to the Director-General on health emergency prevention, preparedness and response, and immediate capacities of the WHE Programme. ii. Beyond and outside of PHEIC: review, provide guidance and make recommendations to the Executive Board regarding the strengthening and oversight of the WHE Programme and for effective health emergency prevention, preparedness and response. 19 Standing Committee on Health Emergency (Pandemic) Prevention, Preparedness and Response. Doc No. EB151(2). Geneva: World Health Organization, 2022. https://apps.who.int/gb/ebwha/pdf_files/EB151/B151(2)-en.pdf – accessed 1 Aug 2022. SEA/RC75/15 Page 51 iii. Work in a manner respectful of and complementary to the technical scientific advice provided by the IHR Emergency Committee. c. Conduct of sessions: i. The Standing Committee shall meet at least twice annually for regular work. In the event of a PHEIC, the Director-General shall convene an extraordinary meeting of the Standing Committee as soon as reasonably practicable, and ideally within 24 hours following the determination of the PHEIC. The Board may decide to convene extraordinary meetings of the Standing Committee. ii. The Standing Committee shall conduct its business on the basis of consensus and transparency. It shall provide a report on each of its meetings to the Executive Board. The meetings of the Standing Committee shall be open for all Member States. iii. The Standing Committee will hold its first meeting after each WHO Region has nominated its members and the Executive Board formally appoints the members through a silence procedure, ideally before the end of October 2022. Actions already taken in the Region 194. The Regional Office for South-East Asia regularly updates the Member States of the Region about the developments regarding various governance-related matters of the WHE Programme, including discussions held by the Independent Oversight and Advisory Committee (IOAC) of the WHE, the global architecture proposals of the Director-General, the Member States Working Group on Strengthening WHO Preparedness and Response to Health Emergencies (WGPR) and the Intergovernmental Negotiating Body (INB). Actions to be taken in the Region 195. The nomination process of the two Member States from the SE Asia Region (who are members of the Executive Board) for the Standing Committee will be taken up during the upcoming Governing Body meetings.

Annexures SEVENTY-FIFTH WORLD HEALTH ASSEMBLY WHA75(11) Agenda item 14.1 28 May 2022 Follow-up to the political declaration of the third high-level meeting of the General Assembly on the prevention and control of non-communicable diseases The Seventy-fifth World Health Assembly, having considered the consolidated report by the Director-General,1 Decided: (1) to note the consolidated report by the Director-General and its annexes;2,3,4 (2) to adopt: • the implementation road map 2023–2030 for the global action plan for the prevention and control of noncommunicable diseases 2013–2030;5 • the recommendations to strengthen and monitor diabetes responses within national noncommunicable disease programmes, including potential targets;6 • the global strategy on oral health;7 • the recommendations on how to strengthen the design and implementation of policies, including those for resilient health systems and health services and infrastructure, to treat people living with noncommunicable diseases and to prevent and control their risk factors in humanitarian emergencies;8 1 Document A75/10 Rev.1. 2 Document A75/10 Add.3 (Annex 5). 3 Document A75/10 Add.5 (Annex 11). 4 Document A75/10 Add.6 (Annex 12). 5 Document A75/10 Add.8 (Annex 1). 6 Document EB150/7 (Annex 2). 7 Document A75/10 Add.1 (Annex 3). 8 Document A75/10 Add.2 (Annex 4). WHA75(11) 2 • the intersectoral global action plan on epilepsy and other neurological disorders 2022–2031;1 • the action plan (2022–2030) to effectively implement the global strategy to reduce the harmful use of alcohol as a public health priority;2 • the recommendations for the prevention and management of obesity over the life course, including considering the potential development of targets in this regard;3 • the workplan for the global coordination mechanism on the prevention and control of noncommunicable diseases 2022–2025;4 (3) to request the Director-General to report on the progress made towards the achievement of global obesity targets, as part of reporting requirements under the acceleration plan, on a biennial basis until 2030. Eighth plenary meeting, 28 May 2022 A75/VR/8 = = = 1 Document A75/10 Add.4 (Annex 7). 2 Document EB150/7, Annex 8; see also document EB150/7 Add.1, which contains the Appendix to Annex 8. 3 Document EB150/7, Annex 9. 4 Document EB150/7, Annex 10. South-East Asia Regional One Voice (ROV): Delivered by Sri Lanka 75th World Health Assembly (WHA 75) Agenda Item 14.1(c): Draft global strategy on oral health and (h) Draft action plan (2022–2030) to effectively implement the global strategy to reduce the harmful use of alcohol as a public health priority First of all, it is my pleasure to speak on behalf of the South East Asia region which represent over a quarter of the world’s population. Though we are at different stages of development in individual countries, on the prevention of Non-Communicable Diseases, we have a common goal to effectively implement global strategies to accelerate prevention and control activities on Non-Communicable Diseases. Utilizing the time period, I am emphasizing on major aspects. 1. Draft global strategy on oral health Oral health is an integral part of wellbeing. Therefore, we strongly recommend integration of oral health into primary healthcare, which often is not happen, due to the fact that treatment of dental problems is of high cost across the world. Also, it is to be mentioned that Oral Health should be an integral part of National Health Policy as we look forward to shift from curative approach to preventive approach, to yield potential benefits. It is important not only to have a global strategy, but a plan of action with inbuilt mechanism to monitor the progress in achieving set targets when implementing the action plan on Oral Health. 2. Regarding reducing the harmful effects of alcohol Our region is concerned that even after a decade since adoption of WHO global strategy, a significant progress could not be yielded. Therefore, we need to focus on attainment of progress as the goal of a comprehensive, effective and sustainable alcohol policy can only be attained by ensuring the active and committed involvement of all relevant stakeholders. Alcohol control strategies need a high degree of public awareness and support in order to be implemented successfully. - 2 - We need to have clear formulation and effective implementation of a rational, integrated and comprehensive alcohol control policy. We strongly encourage an effective monitoring mechanism with regular reviews of national action plans at the regional level and evaluation at the global level in order to implement actions to achieve set targets. We commend the leadership of Madam RD SEARO which had implemented policy not to serve alcoholic beverage at any of official meetings organized by SEARO and Country Offices since 2010. This is the best example of WHO as the global role model in de-normalizing the use of alcohol. SEVENTY-FIFTH WORLD HEALTH ASSEMBLY WHA75.20 Agenda item 14.2 28 May 2022 The global health sector strategies on, respectively, HIV, viral hepatitis and sexually transmitted infections The Seventy-fifth World Health Assembly, Having considered the consolidated report by the Director-General,1 1. NOTES WITH APPRECIATION the global health sector strategies on, respectively, HIV, viral hepatitis and sexually transmitted infections, for the period 2022–2030; 2. REAFFIRMS that in implementing the global health sector strategies on, respectively, HIV, viral hepatitis and sexually transmitted infections, for the period 2022–2030, the national context should be considered; 3. REQUESTS the Director-General to report on the progress made in the implementation of the global health sector strategies on, respectively, HIV, viral hepatitis and sexually transmitted infections, for the period 2022–2030 to the Health Assembly in 2024, 2026, 2028 and 2031, noting that the 2026 report will provide a mid-term review based on the progress made in meeting the strategies’ 2025 targets and the progress made towards achieving the 2030 goals. Ninth plenary meeting, 28 May 2022 A75/VR/9 = = = 1 Document A75/10 Rev.1. SEVENTY-FIFTH WORLD HEALTH ASSEMBLY A75/10 Rev.1 Provisional agenda items 14.1, 14.2, 14.3, 14.4, 14.5, 14.6, 14.7, 16.2, 16.3, 17.1, 17.2, 18.1, 18.2, 21.2, 21.6, 21.8 and 21.9 20 May 2022 Consolidated report by the Director-General1,2 PILLAR 1: ONE BILLION MORE PEOPLE BENEFITING FROM UNIVERSAL HEALTH COVERAGE 14. Review of and update on matters considered by the Executive Board 14.1 Political declaration of the third high-level meeting of the General Assembly on the prevention and control of non-communicable diseases (a) Draft implementation road map 2023–2030 for the global action plan for the prevention and control of noncommunicable diseases 2013–2030 (b) Draft recommendations to strengthen and monitor diabetes responses within national noncommunicable disease programmes, including potential targets (c) Draft global strategy on oral health (d) Draft recommendations on how to strengthen the design and implementation of policies, including those for resilient health systems and health services and infrastructure, to treat people living with noncommunicable diseases and to prevent and control their risk factors in humanitarian emergencies (e) Progress in the implementation of the global strategy to accelerate the elimination of cervical cancer as a public health problem and in the achievement of its associated goals and targets for the period 2020–2030 (f) Progress achieved in the prevention and control of noncommunicable diseases and the promotion of mental health (g) Draft intersectoral global action plan on epilepsy and other neurological disorders in support of universal health coverage 1 In the present document the texts under each agenda item should be read in conjunction with the corresponding reports considered by the Executive Board at its 149th or 150th session, as appropriate. The summary records of those sessions are available at the following link: http://apps.who.int/gb/or/. 2 See also document A75/INF./8 for a note by the Secretariat concerning the various documents on the follow-up to the political declaration of the third high-level meeting of the General Assembly on the prevention and control of noncommunicable diseases. A75/10 Rev.1 2 (h) Draft action plan (2022–2030) to effectively implement the global strategy to reduce the harmful use of alcohol as a public health priority (i) Draft recommendations for the prevention and management of obesity over the life course, including potential targets (j) Draft workplan for the global coordination mechanism on the prevention and control of noncommunicable diseases At its 150th session, the Executive Board noted the reports in documents EB150/7 and EB150/7 Add.1 and adopted decision EB150(4) on the political declaration of the third high-level meeting of the General Assembly on the prevention and control of noncommunicable diseases. In response to requests made during the discussions,1 the Secretariat has slightly revised Annexes 1, 3, 4, 5 and 7,2 and has added an additional Annex 113 on the preparatory process leading to the fourth high-level meeting of the General Assembly on the prevention and control of noncommunicable diseases in 2025 and an Annex 124 on the acceleration plan to support Member States in implementing the recommendations for the prevention and management of obesity over the life course. 14.2 The global health sector strategies on, respectively, HIV, viral hepatitis and sexually transmitted infections The Executive Board at its 150th session noted the report on the global health sector strategies on, respectively, HIV, viral hepatitis and sexually transmitted infections.5 It also adopted resolution EB150.R3, in which it decided that informal consultations on the draft global health sector strategies on respectively, HIV, viral hepatitis and sexually transmitted infections for the period 2022–2030 would continue to be facilitated by the Secretariat prior to the Seventy-fifth World Health Assembly. Additional information on the development process of the strategies, including the informal consultations and the resulting final versions of the strategies in the six official languages, is available online.6 14.3 Global strategy for tuberculosis research and innovation The Executive Board at its 150th session noted the report on the global strategy for tuberculosis research and innovation.7 In the discussions, Board members underscored the impact of the COVID-19 1 See the summary records of the Executive Board at its 150th session, sixth meeting, section 2, seventh meeting, and eighth meeting, section 1. 2 Documents A75/10 Add.8, A75/10 Add.1, A75/10 Add.2, A75/10 Add.3 and A75/10 Add.4, respectively. 3 Document A75/10 Add.5. 4 Document A75/10 Add.6. 5 Document EB150/8; see also the summary records of the Executive Board at its 150th session, eighth meeting, section 2. 6 https://www.who.int/teams/global-hiv-hepatitis-and-stis-programmes/strategies/global-health-sector- strategies/developing-ghss-2022-2030 (accessed 5 April 2022). 7 Document EB150/9; see also the summary records of the Executive Board at its 150th session, eighth meeting, section 2. A75/10 Rev.1 3 pandemic on the fight against tuberculosis and the importance of restoring essential tuberculosis services as quickly as possible. They called for more domestic and international resources to be mobilized in order to accelerate the implementation of the global strategy and achieve faster progress towards global tuberculosis targets. 14.4 Road map for neglected tropical diseases 2021–2030 The Executive Board at its 150th session noted the report on the road map for neglected tropical diseases 2021–2030.1 In the discussions, Board members drew attention to the impact of the COVID-19 pandemic on neglected tropical diseases services. The renewed efforts of Member States were needed to keep the road map targets for neglected tropical diseases on track and ensure that services for those diseases remained part of basic health care. 14.5 Immunization Agenda 2030 The Executive Board at its 150th session noted the report on the Immunization Agenda 2030,2 which summarized the draft global report on the Immunization Agenda 2030 for 2021.3 In the discussions, Board members called for strengthened collaboration between Member States and partners to implement global, regional and national strategies, so as to mitigate the lost momentum in immunization due to the COVID-19 pandemic and renew progress towards the impact goals of the Immunization Agenda 2030. 14.6 Infection prevention and control The Executive Board at its 150th session noted the report on infection prevention and control.4 In the discussions, Board members underscored the importance and urgency of developing a global infection prevention and control strategy to accelerate progress on implementation and monitoring in that area. 14.7 Global road map on defeating meningitis by 2030 The Executive Board at its 150th session noted the report on the global road map on defeating meningitis by 2030.5 In the discussions, Board members expressed support for the establishment of a strategic support group to facilitate the implementation of the road map and emphasized the relevance of strengthening the integration of meningitis prevention and management in primary health care. 1 Document EB150/10; see also the summary records of the Executive Board at its 150th session, eighth meeting, section 2. 2 Document EB150/11; see also the summary records of the Executive Board at its 150th session, eighth meeting, section 3, and ninth meeting, section 1. 3 Sustaining and advancing the Immunization Agenda 2030 during the COVID-19 pandemic: IA2030 global report 2021 (http://www.immunizationagenda2030.org/global-report, accessed 14 April 2022). 4 Document EB150/12; see also the summary records of the Executive Board at its 150th session, eighth meeting, section 3, and ninth meeting, section 1. 5 Document EB150/13; see also the summary records of the Executive Board at its 150th session, eighth meeting, section 3, and ninth meeting, section 1. A75/10 Rev.1 4 PILLAR 2: ONE BILLION MORE PEOPLE BETTER PROTECTED FROM HEALTH EMERGENCIES 16. Public health emergencies: preparedness and response 16.2 Strengthening WHO preparedness for and response to health emergencies The Executive Board at its 150th session noted the reports on strengthening WHO preparedness for and response to health emergencies.1 It also adopted decision EB150(3). 16.3 WHO’s work in health emergencies The Executive Board at its 150th session noted the report on WHO’s work in health emergencies.2 In the discussions, Board members drew attention to the importance of strengthening the WHO Health Emergencies Programme and the Contingency Fund for Emergencies, and of boosting sustainable financing for the Programme and WHO’s emergency functions more broadly. 17. Review of and update on matters considered by the Executive Board 17.1 Influenza preparedness The Executive Board at its 150th session noted the report on influenza preparedness.3 In the discussions, Board members requested the Secretariat to continue reporting on influenza virus-sharing trends and propose solutions to address any disruptions in virus-sharing, and to provide an assessment of the practical, administrative and financial implications for Member States of the proposed expansion of the WHO Global Influenza Surveillance and Response System. 17.2 Global Health for Peace Initiative The Executive Board at its 150th session noted the report on the Global Health for Peace Initiative.4 It also adopted decision EB150(5). 1 Documents EB150/15 and EB150/16; see also the summary records of the Executive Board at its 150th session, fourth meeting, section 4, fifth meeting, and sixth meeting, section 1. 2 Document EB150/18; see also the summary records of the Executive Board at its 150th session, ninth meeting, section 2. 3 Document EB150/19; see also the summary records of the Executive Board at its 150th session, ninth meeting, section 2. 4 Document EB150/20; see also the summary records of the Executive Board at its 150th session, ninth meeting, section 2. A75/10 Rev.1 5 PILLAR 3: ONE BILLION MORE PEOPLE ENJOYING BETTER HEALTH AND WELL-BEING 18. Review of and update on matters considered by the Executive Board 18.1 Maternal, infant and young child nutrition The Executive Board at its 150th session noted the report on maternal, infant and young child nutrition.1 It also adopted decision EB150(7). Additional information on sustaining the elimination of iodine deficiency disorders is provided in a separate document.2 18.2 WHO implementation framework for Billion 3 The Executive Board at its 150th session noted the report on WHO’s implementation framework for Billion 3.3 In the discussions, Board members considered one draft resolution on the outcome of the SIDS Summit for Health: For a healthy and resilient future in small island developing States, and one draft resolution on health promotion and well-being. The Board decided that consultations on both resolutions should continue in the intersessional period. • WHO global strategy for food safety The Executive Board at its 150th session noted the report on the WHO global strategy for food safety.4 It also adopted decisions EB150(8) and EB150(9). PILLAR 4: MORE EFFECTIVE AND EFFICIENT WHO PROVIDING BETTER SUPPORT TO COUNTRIES 21. Review of and update on matters considered by the Executive Board Financial matters 21.2 Scale of assessments 2022–2023 The Executive Board at its 150th session noted the report on scale of assessments 2022–2023.5 It also adopted resolution EB150.R5. 1 Document EB150/23; see also the summary records of the Executive Board at its 150th session, tenth meeting, section 4. 2 Document A75/10 Add.7. 3 Document EB150/24; see also the summary records of the Executive Board at its 150th session, tenth meeting, section 5, and eleventh meeting, section 1. 4 Documents EB150/25 and EB150/26; see also the summary records of the Executive Board at its 150th session, tenth meeting, section 5, and eleventh meeting, section 1. 5 Document EB150/31; see also the summary records of the Executive Board at its 150th session, eleventh meeting, section 2. A75/10 Rev.1 6 Governance matters 21.6 Global strategies and plans of action that are scheduled to expire within one year • Global strategy and plan of action on public health, innovation and intellectual property, for the period 2008–2022 The Executive Board at its 150th session noted the report on the global strategy and plan of action on public health, innovation and intellectual property, for the period 2008–2022.1 It also adopted decision EB150(11). Staffing matters 21.8 Amendments to the Staff Regulations and Staff Rules Having considered the report on amendments to the Staff Regulations and Staff Rules,2 the Board adopted resolutions EB150.R7, EB150.R8 and EB150.R9. 21.9 Report of the International Civil Service Commission The Executive Board at its 150th session noted the report on the International Civil Service Commission.3 ACTION BY THE HEALTH ASSEMBLY The Health Assembly is invited to note this report and the reports contained in documents A75/10 Add.1, Add.2, Add.3, Add.4, Add.5, Add.6, Add.7 and Add.8. The Health Assembly is further invited: • under item 14.1, to adopt the decision recommended by the Executive Board in decision EB150(4) and to consider the following draft decision in relation to the report contained in document A75/10 Add.6: The Seventy-fifth World Health Assembly, having considered the consolidated report of the Director-General and the corresponding Annex 12,4 Decided to request the Director-General to report on the progress made towards the achievement of global obesity targets, as part of reporting requirements under the acceleration plan, on a biannual basis until 2030. 1 Document EB150/36; see also the summary records of the Executive Board at its 150th session, eleventh meeting, section 2. 2 Document EB150/46 Rev.1; see also the summary records of the Executive Board at its 150th session, twelfth meeting, section 2. 3 Document EB150/47; see also the summary records of the Executive Board at its 150th session, twelfth meeting, section 2. 4 Documents A75/10 and A75/10 Add.6. A75/10 Rev.1 7 • under item 14.2, following further informal consultations, to adopt the resolution recommended by the Executive Board in resolution EB150.R3; • under item 14.6, to provide guidance on the way forward in developing a global infection prevention and control strategy; • under item 17.2, to adopt the decision recommended by the Executive Board in decision EB150(5); • under item 18.1, to adopt the decision recommended by the Executive Board in decision EB150(7); • under item 18.2, first bullet, to adopt the decisions recommended by the Executive Board in decisions EB150(8) and EB150(9); • under item 21.2, to adopt the resolution recommended by the Executive Board in resolution EB150.R5; • under item 21.6, first bullet, to adopt the resolution recommended by the Executive Board in decision EB150(11); • under item 21.8, to adopt the resolution recommended by the Executive Board in resolution EB150.R8. = = = EXECUTIVE BOARD EB150/10 150th session 10 December 2021 Provisional agenda item 10 Road map for neglected tropical diseases 2021–2030 Report by the Director-General 1. In 2020 the Seventy-third World Health Assembly issued decision WHA73(33), in which it endorsed the new road map for neglected tropical diseases 2021–2030 and requested the Director-General, inter alia, to report biennially to the Health Assembly, through the Executive Board, on the implementation of the road map. This report is submitted in response to that decision. CONTEXT 2. The coronavirus disease (COVID-19) pandemic has disrupted planning and ongoing activities for neglected tropical diseases globally, regionally and nationally. Progress in implementing the road map must therefore be considered in this context. 3. As the results of most of the indicators for 2021 – the first year of the new road map – will be available only in 2022, this report includes their status as of 2020 or the latest year for which data are available. These data may be considered as the baseline for the new road map and the outcomes of the first road map 2012–2020. 4. The sections below summarize progress in implementing the three pillars of the road map. PROGRESS IN IMPLEMENTING THE ROAD MAP FOR NEGLECTED TROPICAL DISEASES 2021–2030 Pillar 1. Accelerate programmatic action Indicators for the overarching global targets for 2030 5. The indicator used to track the percentage reduction in people requiring interventions against neglected tropical diseases is also indicator 3.3.5 of the Sustainable Development Goals (number of people requiring interventions against neglected tropical diseases). In 2019, 1.74 billion people required interventions. The highest proportion was in the South-East Asia Region (53%), followed by the African (34%), Eastern Mediterranean (5%), Western Pacific (4%), Americas (3%) and European (1%) regions. This was almost 20% less than the 2.19 billion people requiring interventions in 2010, and about 12 million people fewer than reported in 2018.1 1 Global health observatory. Reported number of people requiring interventions against NTDs. Available at https://www.who.int/data/gho/data/indicators/indicator-details/GHO/reported-number-of-people-requiring-interventions- against-ntds, accessed 8 November 2021. EB150/10 2 6. Estimates of disability-adjusted life years are available for 141 of the 20 diseases. In 2019, the last year for which estimates are available,2 the disability-adjusted life years related to neglected tropical diseases were 14.5 million, down from 16.3 million in 2015, and decreased in all regions. 7. By 2020, 42 countries had eliminated at least one neglected tropical disease. In 2021, Gambia became the 43rd country, by being validated as having eliminated trachoma as a public health problem.3 8. In 2020, 732 million people were treated for at least one neglected tropical disease requiring preventive chemotherapy, across 62 countries, achieving global coverage of 42%, down from 66% in 2019, across 81 countries, with a total of 1.1 billion treated. These reductions were among the effects of disruptions to services resulting from the COVID-19 pandemic. Impact on disease-specific targets Diseases targeted for eradication 9. In 2020, six countries reported a total of 27 human cases of dracunculiasis and 1600 infections in animals (mainly among dogs), a reduction of 50% and 20% respectively from 2019. From January to August 2021, eight human cases were reported, a 67% reduction from the comparable period in 2020, and a 57% reduction was reported in the number of infected animals. Five endemic countries (Angola, Chad, Ethiopia, Mali and South Sudan) and two countries that are no longer reporting cases (Democratic Republic of the Congo and Sudan) remain to be certified. Donated azithromycin facilitated mass drug administration for yaws and active surveillance in some endemic countries in the African and Western Pacific regions; laboratory networks are being set up to monitor any potential drug resistance. India remains the only country certified as having interrupted transmission. Diseases targeted for elimination (interruption of transmission) 10. In 2020, 565 cases of gambiense human African trypanosomiasis were reported, a 98% reduction since 2000. Reports on leprosy were received from 133 countries, of which 31 reported zero cases. Globally, 127 572 new cases were reported; 8626 (7%) were in children. By 2020, the number of new cases had decreased by 10%, as had the numbers of affected children and patients with new disabilities. Four countries in the Region of the Americas were verified as having interrupted transmission of onchocerciasis. Treatment continues in endemic countries in all affected regions. Diseases targeted for elimination as a public health problem 11. Progress against Chagas disease included global advocacy through the inaugural World Chagas Disease Day held on 14 April 2020. A global virtual event4 focused on health promotion, public 1 African trypanosomiasis, Chagas disease, cysticercosis, dengue, echinococcosis, food-borne trematodes, leishmaniasis, leprosy, lymphatic filariasis, onchocerciasis, rabies, schistosomiasis, soil-transmitted helminthiases (ascariasis, trichuriasis and hookworm disease) and trachoma. 2 Global health observatory. Global health estimates 2019: Leading causes of DALYs. Available at https://www.who.int/data/gho/data/themes/mortality-and-global-health-estimates/global-health-estimates-leading-causes-of- dalys, accessed 8 November 2021. 3 WHO Alliance for the Global Elimination of Trachoma by 2020: progress report on elimination of trachoma, 2020. Wkly Epidemiol Rec. 2021;96(31):35364. 4 World Chagas Disease Day. 14 April 2021 (https://www.who.int/campaigns/world-chagas-disease-day/2021, accessed 18 November 2021). EB150/10 3 information and education, advocacy for action and the need to address discrimination and stigma associated with the disease. Held in the early months of the pandemic, the online event brought together countries, regional offices, donors, partners, patients and patient organizations, and health care providers. It was widely reported in the press, with high uptake on social media platforms. A five-year programme to eliminate congenital Chagas disease was endorsed by member countries of the Organization of Ibero-American States. Interruption and control of domiciliary vector transmission and universal screening for Chagas disease in blood donors was maintained in the Region of the Americas. 12. Despite an outbreak of rhodesiense human African trypanosomiasis in 2019–2020 resulting in 214 cases, the trend in the number of cases from 2000 to 2020 shows a decrease of 84%. In 2020, the number of reported cases of visceral leishmaniasis fell to 12 739, the lowest number since 1998. In the South-East Asia Region, 98% of implementation units achieved the epidemiological threshold of elimination as a public health problem. By 2020, cumulative reductions of 74% in lymphatic filariasis infections and 49% in the population requiring mass treatment had been achieved. Seventeen countries or territories1 have been validated for eliminating this disease as a public health problem. Deworming against soil-transmitted helminthiases continued at a reduced pace because of COVID-19-related closures of schools and vaccination services. Since 2020, one additional country (Gambia) has been validated as having eliminated trachoma as a public health problem, bringing the total to 11 countries validated as having eliminated this disease. The estimated global total number of people with trachomatous trichiasis was 1.8 million on 21 June 2021, down from 2.0 million cases on 1 May 2020. Diseases targeted for control 13. Nine diseases or groups of diseases2 are targeted for control. Progress has been made in different areas, including support to pilot interventions for echinococcosis, foodborne trematodiases and taeniasis/cysticercosis in selected countries; supply of medicines for case management of cutaneous leishmaniasis, especially in crisis-affected countries in the Eastern Mediterranean Region; and follow-up with partners and donors on the evaluation of a new medicine for mycetoma (fosravuconazole) and on the improvement of access to existing treatment for chromoblastomycosis and scabies. With regard to snakebite envenoming, the Snakebite Information and Data Platform3 was launched in September 2021 and includes information on the world’s venomous snake species and their distribution, as well as an up-to-date database on antivenoms and their manufacturers. 14. Efforts are also being made to address the growing challenge of Aedes-borne arboviral diseases, including review of country-level activities and build-up of preparedness and response for dengue, given that in 2019 many countries were affected by this disease. WHO is working on a Global Arbovirus Initiative, focusing initially on Aedes-borne arboviral diseases, which will strengthen the coordination, communication, capacity-building, research, preparedness and response necessary to mitigate the growing risk of epidemics due to arboviral diseases. 1 Malawi and Togo (African Region); Maldives, Sri Lanka and Thailand (South-East Asia Region); Egypt and Yemen (Eastern Mediterranean Region); Cambodia, Cook Islands, Kiribati, Marshall Islands, Niue, Palau, Tonga, Vanuatu, Viet Nam, and Wallis and Futuna (Western Pacific Region). 2 Buruli ulcer; dengue; echinococcosis; foodborne trematodiases; leishmaniasis (cutaneous); mycetoma, chromoblastomycosis and other deep mycoses; scabies and other ectoparasitoses; snakebite envenoming; and taeniasis and cysticercosis. 3 Available at https://www.who.int/teams/control-of-neglected-tropical-diseases/snakebite-envenoming/snakebite- information-and-data-platform, accessed 18 November 2021. EB150/10 4 Challenges and the way forward 15. Interventions and activities were significantly disrupted due to the COVID-19 pandemic across the entire spectrum of essential health services. According to a recent survey,1 as of early 2021, services for neglected tropical diseases were the second most frequently disrupted (44% of countries; 48/109), after those targeting mental, neurological and substance use disorders. Some 60% of countries reported disruption to preventive chemotherapy. The main public health consequences of these disruptions are delays in achieving the global, regional and national public health goals set for relevant diseases. 16. Delays in manufacture, supply chain issues, shipment and delivery of medicines and consumables to and within target countries exacerbated challenges in ensuring the availability and timely utilization of medicines. Medicines with a short shelf life, such as praziquantel, are especially vulnerable to expiration as a result of disrupted delivery channels. 17. The following measures were taken to mitigate the impact of the COVID-19 pandemic on services for neglected tropical diseases: (a) Technical guidance was developed for national health authorities and implementers on adapting activities to enable their safe implementation in the context of the pandemic. Global guidance was further adapted by WHO regional offices and implementation partners as tools and other resources; (b) Guidance documents were issued on the safe adaptation of both community-based2 and health facility-based services for neglected tropical diseases,3 as well as on the resumption of community-based activities relying on a risk-based approach;4 (c) An online training course dedicated to neglected tropical diseases in the context of the pandemic5 was made available on the OpenWHO platform in Arabic, English, French, Spanish and Portuguese; updated guidance was also issued on the use of masks in community outreach activities;6 1 Second round of the national pulse survey on continuity of essential health services during the COVID-19 pandemic, January–March 2021: interim report, 22 April 2021. Geneva: World Health Organization, 2021 (https://apps.who.int/iris/handle/10665/340937, accessed 8 November 2021). 2 Community-based health care, including outreach and campaigns, in the context of the COVID-19 pandemic: interim guidance, May 2020. Geneva: World Health Organization; 2020 (https://apps.who.int/iris/handle/10665/331975, accessed 8 November 2021). 3 Maintaining essential health services: operational guidance for the COVID-19 context, interim guidance 1 June 2020. Geneva: World Health Organization; 2020 (https://apps.who.int/iris/handle/10665/332240, accessed 8 November 2021). 4 Considerations for implementing mass treatment, active case-finding and population-based surveys for neglected tropical diseases in the context of the COVID-19 pandemic: interim guidance, 27 July 2020. Geneva: World Health Organization; 2020 (https://apps.who.int/iris/handle/10665/333499, accessed 8 November 2021). 5 Available at https://openwho.org/courses/covid-19-ntd-en (accessed 8 November 2021). 6 Aide memoire: use of medical and non-medical/fabric masks for community outreach activities during the COVID-19 pandemic, based on current WHO guidance, 31 May 2021. Geneva: World Health Organization; 2020 (https://apps.who.int/iris/handle/10665/341570, accessed 8 November 2021). EB150/10 5 (d) Review of requests and re-scheduling of plans prevented loss of medicines with short shelf-lives from expiring; production, shipment, delivery and distribution of medicines and other medical consumables was closely followed up with all relevant actors; (e) In collaboration with academic institutions, mathematical modelling exercises were conducted to assess the impact of disruptions on timelines for achieving public health targets for selected diseases, and the benefits of remedial strategies.1 Pillar 2. Intensify cross-cutting approaches 18. Work at global and national levels is helping to better position services for neglected tropical diseases within health systems and primary health care. Interventions against neglected tropical diseases are included in the compendium of universal health care. Linkages with other health services are being promoted where diseases overlap in distribution and potentially impact one another. 19. To effectively tackle the burden of neglected tropical diseases of the skin, a framework was published to guide relevant national programmes in integrating their management at primary health care level. In addition, WHO developed a smartphone App aimed at assisting health workers in the identification of skin conditions through a visual inspection of the lesions and the assessment of their associated signs and symptoms.2 20. There are strong epidemiological associations between inadequate access to water, sanitation and hygiene and a wide range of conditions, including several neglected tropical diseases. Nevertheless, 1.6 billion people still lack access to safe drinking-water at home, 2.8 billion do not have access to safe sanitation and 1.9 billion lack basic domestic hand-washing facilities.3 21. The strategic objectives of the updated global strategy on water, sanitation and hygiene4 are to increase awareness of the co-benefits of joint action and engagement; use data on water, sanitation and hygiene in neglected tropical disease programmes, and vice versa to guide informed decision-making; strengthen evidence and establish best practice on integrated approaches; and jointly plan, deliver and evaluate programmes. 22. Most neglected tropical diseases occur at the human–animal interface. Implementing One Health approaches to prevent and manage these diseases generates momentum for substantial long-term gains. Attending to diseases strengthens health systems and builds baseline data to better manage both the endemic diseases with a human–animal interface and the emerging infectious diseases and pandemic threats. Activities focus on multisectoral approaches and practices to drive policy, behaviour change and 1 Impact of the COVID-19 pandemic on seven neglected tropical diseases: a model-based analysis. Geneva: World Health Organization; 2021 (https://apps.who.int/iris/handle/10665/343993, accessed 8 November 2021). 2 Available for Android at https://play.google.com/store/apps/details?id=com.universaldoctor.skin_ntds&hl=en&gl=US, and for iOS at https://apps.apple.com/us/app/skin-ntds-app/id1499080526. 3 Progress on household drinking water, sanitation and hygiene 2000–2020: five years into the SDGs. Geneva: World Health Organization; 2021 (https://apps.who.int/iris/handle/10665/345081, accessed 8 November 2021). 4 Ending the neglect to attain the Sustainable Development Goals. A Global strategy on water, sanitation and hygiene to combat neglected tropical diseases 2021–2030. Geneva: World Health Organization; 2021 (https://www.who.int/publications/i/item/9789240022782, accessed 8 November 2021). EB150/10 6 surveillance, and build capacities to prevent and control priority health risks that occur at the human-animal interface, with the involvement of all sectors and partners nationally and locally. 23. Many neglected tropical diseases are vector-borne and benefit from the Global Vector Control Response 2017–2030, welcomed by the Seventieth World Health Assembly in resolution WHA70.16 (2017). A Joint Action Group is coordinating the implementation of this strategy at regional and country levels. An online platform for monitoring progress was established in 2020. All regions developed a related policy, strategy or recommendations. Country-level support was provided. A global survey indicated that the response is on track for some priority activities, for example vector control strategic plans, but milestones were not reached for other activities such as vector-control needs assessments. Impact indicators showed a 9.7% reduction in global mortality. Overall, progress in implementation remained modest due to funding shortfalls and insufficient human resources at all levels. Pillar 3. Change operating models and culture to facilitate country ownership 24. A framework to guide countries in developing sustainable plans for the control and elimination of neglected tropical diseases was published. WHO’s regional and country offices, in close collaboration with health ministries and partners, provided technical support to frame sustainable annual and multi-year programmes. Partnership and donor engagement remain crucial. Medicine donations and financial agreements were renewed with pharmaceutical companies and other partners. Other actions taken in support of the road map 25. The road map was disseminated in all six official languages, in print, online and as a smartphone App;1 and three companion documents were published to provide further guidance on the strategic shifts advocated in the road map. 26. Global online webinars were organized by WHO to advocate for the continued and safe implementation of activities on neglected tropical diseases in the context of the COVID-19 pandemic. These webinars started in 2020 and continued in 2021 with a stronger focus on the road map, supported by relevant news releases, infographics and audio-visual products. Virtual meetings of national programme managers and partners organized by regional offices provided further exposure to the road map and its operating principles. 27. New online courses aimed at strengthening capacities and facilitating implementation of the road map at global and country levels are currently being developed. A channel dedicated to neglected tropical diseases was launched on the Open WHO platform,2 with courses on mycetoma, podoconiosis, rabies/One Health, scabies and tungiasis, in addition to the above-mentioned course on neglected tropical diseases and COVID-19. 28. Overcoming the diagnostics gaps. The Diagnostic Technical Advisory Group on neglected tropical diseases is addressing the existing critical gaps in diagnostics. Target product profiles were published for prioritized use cases for human African trypanosomiasis (rhodesiense) lymphatic filariasis, onchocerciasis, soil-transmitted helminthiases and are in development for human African trypanosomiasis (gambiense) and neglected tropical diseases of the skin. Regulatory and manufacturing pathways to facilitate prequalification and regulatory approval of in-vitro diagnostics are being explored. 1 Available for iOS at https://apps.apple.com/us/app/ntd-road-map-2021-2030/id1549823959, and for Android at https://play.google.com/store/apps/details?id=org.who.NTDROADMAP. 2 Available at https://openwho.org/channels/ntd (accessed 8 November 2021). EB150/10 7 A group of donors and partners has been engaged to advocate for the required investment to translate the target product profiles into diagnostic products and to address the access issues. 29. Monitoring and evaluation. The monitoring, evaluation and research working group, under the aegis of the Strategic Technical and Advisory Group for Neglected Tropical Diseases, endorsed a framework to support implementation of the road map in the context of national routine health information systems. 30. Ensuring access and logistics for medicines and health products. Quality-assured medicines and health products remain the cornerstone of successful interventions against neglected tropical diseases. 31. Three formulations of albendazole, praziquantel and ivermectin were prequalified in 2021, bringing to nine the total number of medicinal products for treatment of neglected tropical diseases in the WHO prequalified list. 32. Technical advice and guidance were provided to manufacturers, product development partnerships and academic institutions on prequalification requirements and access strategy through the collaborative procedure for accelerated registration of WHO-prequalified finished pharmaceutical products. 33. Donated medicines and health products have strengthened support to neglected tropical disease programmes in affected countries. During 2020–2021, over 4.7 billion medicines and health products were made available to 112 Member States free of charge. ACTION BY THE EXECUTIVE BOARD 34. The Board is invited to note the report; in its discussions it is further invited to provide guidance on sustaining implementation of the road map and ensuring that interventions against neglected tropical diseases are considered as part of essential health services in the context of the COVID-19 pandemic. = = = EXECUTIVE BOARD EB150/11 150th session 13 December 2021 Provisional agenda item 11 Immunization Agenda 2030 Report by the Director-General 1. The Seventy-third World Health Assembly, having adopted the written silence procedure through decision WHA73(7) (2020), decided inter alia:1 (1) to endorse the new global vision and overarching strategy for vaccines and immunization: Immunization Agenda 2030; (2) to request the Director-General to continue to monitor progress and to report biennially as a substantive agenda item to the Health Assembly, through the Executive Board, on the achievements made in advancing towards the global goals of the Immunization Agenda 2030, starting with the Seventy-fifth World Health Assembly. 2. The draft global report on the Immunization Agenda 2030 for 2021, summarized here, compiles the baseline data that will be used to track progress in immunization up to 2030, reports progress towards the Immunization Agenda 2030 goals set in 2020, and details the implementation status of the Immunization Agenda 2030 at country, regional and global levels. PROGRESS TOWARDS THE IMMUNIZATION AGENDA 2030 GOALS 3. The Immunization Agenda 2030 includes seven indicators that track progress towards its three impact goals: (a) reduce mortality and morbidity from vaccine-preventable diseases for everyone throughout the life course; (b) leave no one behind, by increasing equitable access and use of new and existing vaccines; and (c) ensure good health and well-being for everyone by strengthening immunization within primary health care and contributing to universal health coverage and sustainable development. 4. In 2020, compared to the 2019 baseline data, disruption caused by the coronavirus disease (COVID-19) pandemic led to regression in many immunization indicators (Annex 1). COVID-19 caused significant supply-side disruption, including staff shortages due to ill-health or redeployment, interruption of service delivery and disruption of supply chains, and had demand-side consequences, with reduced take-up of health services. 5. Key consequences included a decline in vaccination coverage for most vaccines, with global coverage of DTP3 (diphtheria, tetanus and pertussis-containing vaccine, third dose) falling from 86% in 1 Decision WHA73(9) (2020). EB150/11 2 2019 to 83% in 2020. The number of zero-dose children (not receiving any DTP doses) rose by 3.5 million, from 13.6 million in 2019 to 17.1 million in 2020, the first increase in a decade. 6. Impact goal 1.1: Future deaths averted. Modelling indicates that an estimated 51 million future deaths in total will be averted by vaccination between 2021 and 2030, if coverage targets are met. The decline in vaccination coverage seen in 2020 raises serious questions about the achievability of this target, unless major catch-up vaccination efforts are put in place. 7. Impact goal 1.2: Number of countries achieving regional or global control, elimination and eradication targets: (a) In 2020, Nigeria was certified polio-free after three years without detection of wild poliovirus, leading to certification of the entire African continent by the Africa Regional Certification Commission for Polio Eradication. This was a major achievement in the fight for a world free of polio. However, wild poliovirus remains endemic in Afghanistan and Pakistan; (b) The number of countries having achieved measles elimination reached 81 in 2019 (full data for 2020 are not yet available). However, during 2016–2020, transmission was re-established in 10 countries that had previously achieved elimination. Furthermore, compared to 2019, an additional three million children did not receive any measles-containing vaccine (MCV), leaving 22.3 million children unprotected. A further 18.2 million children received only one dose of MCV and remain at risk of measles; (c) Two additional countries achieved elimination of rubella in 2020. All countries achieving rubella elimination have sustained it. 8. Impact goal 1.3: Number of large or disruptive vaccine-preventable disease outbreaks. The number of circulating vaccine-derived poliovirus (cVDPV) outbreaks increased from 22 in 2019 to 33 in 2020. Measles outbreaks fell substantially, from 76 in 2019 to 26 in 2020. This could reflect several factors, including COVID-19 public health and social measures, disrupted surveillance, and protection of children affected by measles outbreaks in preceding years. The numbers of outbreaks of other vaccine-preventable diseases remained mostly stable. 9. Impact goal 2.1: Numbers of zero-dose children. The numbers of zero-dose children increased from 13.6 million in 2019 to 17.1 million in 2020. Such a large backwards step has not been seen for more than a decade. 10. Impact goal 2.2: Introduction of new or under-utilized vaccines in low- and middle-income countries. Only 22 vaccine introductions into the national immunization schedules of low- and middle-income countries were reported in 2020, the lowest number of annual introductions in the past decade. This decrease probably reflects pandemic pressures on health systems, limited capacity to mobilize funding, and de-prioritization of expansion of services. 11. Impact goal 3.1: Vaccination coverage across the life course. Coverage for three of the four indicators used to assess vaccination coverage at different life stages1 declined globally between 2019 and 2020: DTP3 from 86% to 83%, MCV2 from 71% to 70%, and HPV from 15% to 13%. PCV3 coverage increased marginally from 48% to 49%. New PCV3, MCV2 and HPV introductions added to 1 DTP3 (year 1), MCV2 (year 2), third dose of pneumococcal conjugate vaccine (PCV3, childhood), and the complete course of human papillomavirus vaccine (HPVc, adolescence). EB150/11 3 global coverage, offsetting drops in coverage in other countries. Despite new introductions in 2020, global HPV vaccine coverage decreased for the first time in 2020, leaving an estimated additional 1.5 million girls unprotected against cervical cancer. 12. Impact goal 3.2: Universal health coverage service coverage index. This indicator tracks immunization’s contribution to enhancing primary health care and universal health coverage. Data are not yet available for 2020. However, the 2020 Goalkeepers Report assessed global progress using an alternative index of tracer interventions and found substantial regression in the coverage of essential health services in 2020 due to COVID-19. 13. Strategic priority indicators: The 15 global strategic priority objectives indicators track performance at country, regional and global levels, to identify potential root causes of success and failure and possible actions for improvement. No global targets have been set, due to wide country and regional variations. 14. As many indicators are new, some 2020 data are not available. Annex 2 shows baseline and 2020 data where they are available. 15. Data on vaccination coverage in 2020 across the life course showed limited or no improvement. Average coverage for vaccines targeting 11 diseases across multiple age ranges stood at 69%, compared with 70% in 2019. 16. At subnational levels, coverage in the 20% of worst-performing districts fell for DTP3 (74% to 71%), MCV1 (72% to 69%) and MCV2 (65% to 60%). These falls were greater than those seen for global coverage, suggesting that poor-performing districts fell further behind in 2020, increasing inequities in vaccination coverage. 17. Overall, immunization took a step backwards in 2020. Despite the tireless efforts of countless immunization programme staff working to ensure the availability of vaccination services, vaccination coverage globally fell for the first time in a decade. Catch-up of lost ground and regenerating the momentum towards universal vaccination coverage are therefore critical priorities for the years ahead. IMPLEMENTATION OF THE IMMUNIZATION AGENDA 2030 18. At the Seventy-fourth World Health Assembly in May 2021, Member States expressed overwhelming support for the implementation of the Immunization Agenda 2030 through the Framework for Action.1,2 The Framework for Action detailed how coordinated operational planning, monitoring and evaluation, ownership and accountability, and communications and advocacy are key drivers for implementation and impact on the ground. It emphasizes the particular role of regions and countries. 19. Regions have finalized, or are developing, regional strategies aligned with the Immunization Agenda 2030. Following consultations with regional immunization technical advisory groups, either regional Immunization Agenda 2030 strategies or frameworks to develop regional strategies for Africa, 1 See the summary records of the Seventy-fourth World Health Assembly, Committee A, seventh meeting, (section 2) and ninth meeting. 2 Implementing the Immunization Agenda 2030: A Framework for Action through Coordinated Planning, Monitoring & Evaluation, Ownership & Accountability, and Communications & Advocacy (http://www.immunizationagenda2030.org/framework-for-action). EB150/11 4 the Americas, Europe, South-East Asia and the Western Pacific regions have been approved by WHO regional committees. 20. Regions are also developing implementation plans, generally up to 2025. Regions are continuing the Immunization Agenda 2030’s collaborative approach through co-creation with countries and partners. For example, the African, South-East Asia, European and Western Pacific regions conducted regional surveys and/or convened discussions with countries to establish priorities. 21. Regional implementation plans are typically focusing on the twin aims of COVID-19 vaccine introduction and recovery and scale-up of immunization activities to recover lost ground and to “build back better”. 22. To support countries in strategy development and ensure alignment with the Immunization Agenda 2030, WHO and partners have developed a new strategic framework within the national immunization strategy initiative. Four countries piloted national immunization strategy development using the new guidelines in 2020–2021. 23. Thirteen working groups are taking forward technical work across the seven Immunization Agenda 2030 strategic priorities. Others are focusing on areas such as monitoring and evaluation, and communications and advocacy (Annex 3). 24. Working groups will undertake “consultative engagement” with regional partners and country implementers, to explore local challenges and innovative new practices. They will provide an annual commentary on data relating to their specialist areas and make recommendations to countries, partners and others. 25. The outputs of working groups will be a critical technical resource for regions, countries and partners. They will provide much of the “fuel” to help drive change at the country level. 26. The Immunization Agenda 2030 Partnership Council convened for an inaugural session on 22 September 2021. It will meet twice a year and sign off on the Immunization Agenda 2030 reporting to the World Health Assembly biannually, starting in 2022. It is composed of 10 to 12 senior leaders, including representatives of countries, regions and civil society. 27. The day-to-day management of the Immunization Agenda 2030 is the responsibility of the Immunization Agenda 2030 Coordination Group, which has met monthly since May 2021, supported by a small virtual Immunization Agenda 2030 secretariat. The coordination group has nine director-level members from partner organizations and is co-chaired by WHO and UNICEF. 28. Annex 4 provides an overview of key implementing bodies involved in Immunization Agenda 2030. The Agenda’s global-level partnership is described in detail in Annex 2 to the Framework for Action. 29. The Immunization Agenda 2030 was formally launched during World Immunization Week 2021. Launch activities engaged many partners and leveraged multiple platforms, communicating the Agenda’s vision and objectives to global audiences. 30. The Seventy-fourth World Health Assembly in May 2021 presented an opportunity for governments to publicly commit to the Immunization Agenda 2030, galvanizing other countries to follow suit. A historic cross-regional statement was made on behalf of the six WHO regions and EB150/11 5 50 countries, reiterating the Agenda’s targets and key messages and calling on world leaders to make explicit and sustainable commitments to the Agenda. 31. A virtual Immunization Agenda 2030 United Nations General Assembly event was organized in September 2021 and further communications and advocacy activities are planned to sustain this momentum. 32. As the Immunization Agenda 2030 structures are still being put in place, 2021 is a transitional year for reporting of immunization data. Future Immunization Agenda 2030 reporting will be novel in several ways. (a) Regions and countries will tailor their monitoring and evaluation frameworks to their specific needs, and only a minimum of impact and strategic priority indicators will be followed at global level. (b) Indicator reporting at the global level will be led by the Immunization Agenda 2030 working groups and will include comprehensive data analysis and recommendations for action. (c) Monitoring, evaluation and action cycles will be defined to link reporting to ownership and accountability, and to communications and advocacy, to drive actions by all stakeholders. (d) Feedback loops will be established to monitor follow-up of recommendations made by groups such as the Strategic Advisory Group of Experts on Immunization (SAGE) and regional immunization technical advisory groups. 33. SAGE will be provided with an annual Immunization Agenda 2030 technical progress report and updates from WHO regional offices. It will provide feedback to the working groups, regions and countries, the Immunization Agenda 2030 Coordination Group, and the Immunization Agenda 2030 Partnership Council. CONCLUSIONS AND NEXT STEPS 34. Following a decade of only limited progress, the COVID-19 pandemic has had a highly damaging impact on immunization. Millions more young children are now at risk of life-threatening infectious diseases. 35. With the world in emergency mode, immunization staff working at all levels nationally, regionally and globally have been diverted to COVID-19 responses. It is time to establish more sustainable COVID-19 responses while restoring financial and human resources to essential immunization services, including surveillance at every level. 36. To achieve the Immunization Agenda 2030 vision and goals, the global community needs to act urgently to enable countries to halt and reverse the declines in coverage seen in 2020 and to re-energize progress towards Immunization Agenda 2030 targets. EB150/11 6 37. Partners working at country, regional and global levels need to work collaboratively to enable countries to: (a) perform country-by-country analyses of current strengths and weaknesses and the areas most affected by COVID-19-related disruption. Such analyses will indicate gaps and needs in each country and priority areas for action; (b) plan tailored actions at country, regional and global levels to respond to the underlying reasons for underperformance in each country. These should include targeted campaigns to reduce the immediate risk of outbreaks; and (c) use the momentum generated by political and societal interest in COVID-19 vaccines to build public and political support for the strengthening of immunization programmes. This will require strong advocacy at global, regional and country levels to prioritize immunization services across all relevant organizations. 38. The near term will inevitably be dominated by a continuing focus on COVID-19 vaccine roll-outs. Nevertheless, it is vital that these activities are also used to increase capacity, strengthen vaccine delivery infrastructure, improve data systems and enhance disease surveillance. This will help revitalize the fight against all vaccine-preventable diseases and lay the foundation for further progress over the next decade. ACTION BY THE EXECUTIVE BOARD 39. The Board is invited to note the report; in its discussions it is further invited to provide guidance on: • accelerating development and implementation by Member States of national immunization strategies; and • strengthening collaboration between Member States and partners to implement global, regional and national strategies in order to mitigate lost momentum in immunization due to the COVID- 19 pandemic and renew progress towards the impact goals of the Immunization Agenda 2030; EB150/11 7 ANNEX 1: IMMUNIZATION AGENDA 2030 IMPACT GOAL INDICATORS AND TARGET, BASELINE AND 2020 DATA* *Full details of each indicator can be found in Annex 1 of the Immunization Agenda 2030 Framework for Action. **In addition, seven low- and middle-income countries began to use COVID-19 vaccines in 2020. Key: WPV: wild poliovirus; cVDPV: circulating vaccine-derived poliovirus; MNT: maternal and neonatal tetanus; JE: Japanese encephalitis; DTP3: diphtheria, tetanus and pertussis-containing vaccine, third dose; MCV2: measles containing vaccine, second dose; PCV: pneumococcal conjugate vaccine; HPVc: human papillomavirus vaccine, complete series Baseline (year) 2020 1.1 Number of future deaths averted by immunization 50 million future deaths averted by immunization in 2021–2030 4.3 million (2019) N/A Midpoint review expected in 2025 1.2 Number and % of countries achieving endorsed regional or global vaccine- preventable disease control, elimination and eradication targets All countries achieve endorsed targets Baseline data for 2021 will be reported in 2022 Provisional 2019 data for a subset of vaccine-preventable diseases: Provisional 2020 data for a subset of vaccine-preventable diseases: WPV cVDPV Measles Rubella MNT Hepatitis B JE 191 (98.5%) pending 81 (55.1%) 88 (69.8%) pending pending pending WPV cVDPV Measles Rubella MNT Hepatitis B JE 192 (99.0%) pending 80 (54.4%) 90 (71.4%) pending pending pending 1.3 Number of large or disruptive vaccine- preventable disease outbreaks Declining trend in the annual number of large or disruptive vaccine-preventable disease outbreaks Cholera Ebola virus Measles Meningococcus cVDPV WPV Yellow fever 1 1 51 2 21 2 4 Cholera Ebola virus Measles Meningococcus cVDPV WPV Yellow fever 1 1 26 0 33 2 5 (average annual number of outbreaks over 2018–2020) 2.1 Number of zero-dose children 50% reduction in number of zero-dose children 13.6 million (2019) 17.1 million 2.2 Introductions of new or under-utilized vaccines in low- and middle- income countries 500 vaccine introductions by end of 2030 A baseline is not applicable for this indicator, which will count the cumulative number of vaccine introductions between 2021 and 2030 (An average of 54 annual introductions were reported during 2011–2020) 22 introductions** 3.1 Vaccination coverage across the life course 90% coverage of full course for selected vaccines DTP3 MCV2 PCV3 HPVc 86% 71% 48% 15% (2019) DTP3 MCV2 PCV3 HPVc 83% 70% 49% 13% 3.2 Universal health coverage service coverage index Universal health coverage increase in all countries, regions, and globally Global Africa Americas Eastern Med Europe South-East Asia Western Pacific 64.0 47.0 73.0 61.6 75.5 60.2 65.4 N/A (2017, pending 2019 data) EB150/11 8 ANNEX 2 IMMUNIZATION AGENDA 2030 STRATEGIC PRIORITY (SP) INDICATORS – BASELINE AND 2020 DATA Indicator (data source) Baseline (year) 2020 SP 1.1: Proportion of countries with evidence of adopted mechanism for monitoring, evaluation and action at national and subnational levels (WHO/UNICEF electronic Joint Reporting Form (eJRF) – pilot testing of questions in 2021) Data expected to be available in June 2022 (2021) Next reporting year is 2022 SP 1.2: Density of physicians, nurses and midwives per 10,000 population (WHO National Health Workforce Accounts) Physicians: 17.4 Nurses and midwives: 39 (2019) 2020 data expected to be available in December 2021 SP 1.3: Proportion of countries with on-time reporting from 90% of districts for suspected cases of all priority vaccine-preventable diseases included in nationwide surveillance (eJRF – pilot testing of questions in 2021) Data expected to be available in June 2022 (2021) Next reporting year is 2022 SP 1.4: Proportion of time with full availability of DTP-containing vaccine (DTPcv) and MCV at service delivery level (eJRF – pilot testing of questions in 2021) Data expected to be available in June 2022 (2021) Next reporting year is 2022 SP 1.6: Proportion of countries with at least one documented (with reporting form and/or line-listed) individual serious adverse event following immunization; case safety report per million total population (WHO global database VigiBase) 54 of 194 countries (2019) 52 of 194 countries SP 2.1: Proportion of countries with legislation in place that is supportive of immunization as a public good (eJRF – pilot testing of questions in 2021) Data expected to be available in June 2022 (2021) Next reporting year is 2022 SP 2.2: Proportion of countries that have implemented behavioural or social strategies (in other words, demand generation strategies) to address under-vaccination (eJRF – pilot testing of questions in 2021) Data expected to be available in June 2022 (2021) Next reporting year is 2022 SP 3.2: DTP3, MCV1, and MCV2 coverage in the 20% of districts with lowest coverage (mean across countries) (eJRF) DTP3: 74% MCV1: 72% MCV2: 65% (2019) DTP3: 71% MCV1: 69% MCV2: 60% (2020) SP 4.1: Breadth of protection (mean coverage for all WHO-recommended vaccine antigens) (eJRF; WHO and UNICEF Estimates of National Immunization Coverage (WUENIC) 70% (2019) 69% SP 5.1: Proportion of polio, measles, meningococcus, yellow fever, cholera and Ebola virus outbreaks with timely detection and response (International Coordinating Group (ICG); Measles and Rubella Initiative; Global Polio Eradication Initiative (GPEI); WHO, national immunization and disease surveillance programmes) Data expected to be available in June 2022 (2021) Next reporting year is 2022 SP 6.1 Health of vaccine markets, disaggregated by vaccine antigens and country typology (UNICEF/WHO via the Marketing Information for Access to Vaccines (MI4A) initiative; Gavi, the Vaccine Alliance secretariat, Bill & Melinda Gates Foundation) Healthy: 3 Unhealthy: 3 (2019) Unhealthy: 3 Concerning: 6 Healthy: 3 SP 6.2: Proportion of countries where domestic government and donor expenditure on primary health care increased or remained stable (WHO Global Health Expenditure Database (GHED)) Data expected to be available in December 2021 (2019) Data not yet available SP 6.3: Proportion of countries where the share of national immunization schedule vaccine expenditure funded by domestic government resources increased or remained stable (eJRF) 19 out of 36 low and low-middle income countries* (2019) 24 out of 36 countries SP 7.1: Proportion of countries with an immunization research agenda (eJRF – pilot testing of questions in 2021) Data expected to be available in June 2022 (2021) Next reporting year is 2022 SP 7.2: Progress towards global research and development targets (literature review) Data expected to be available October 2022 (2021–2022) *Only 36 low- and lower-middle-income countries reported data during 2018–2020. EB150/11 9 ANNEX 3 RELATIONSHIPS BETWEEN KEY IMMUNIZATION AGENDA 2030 STAKEHOLDERS Key. SAGE: Strategic Advisory Group of Experts on Immunization; RITAG: Regional immunization technical advisory group; NITAG: national immunization technical advisory group; WGs: working groups; O&A: ownership and accountability; M&E: monitoring and evaluation; C&A: communications and advocacy; CSOs: civil society organizations EB150/11 10 ANNEX 4 STATUS OF OPEN AUDIT RECOMMENDATIONS AS AT 19 JANUARY 2021 Focus area Lead partner Key deliverables planned 2021–2022 SP1: Primary health care/universal health coverage United States Agency for International Development (USAID) • Contribute to WHO Toolkit of three integrated primary health care resources • Develop resource on strengthening immunization programmes and primary health care during COVID-19 vaccine roll-out and organize learning webinar • Convene consultation on integrating immunization into primary health care/universal health coverage • Jointly develop a conceptual framework for integrating primary health care and connecting across the Immunization Agenda 2030 strategic priorities and with broader universal health care/primary health care SP2: Commitment and demand WHO/Jon Snow Inc. • Publish action-oriented policy brief to support country-level and multistakeholder efforts to mobilize domestic and other funding sources • Facilitate webinars to: (1) promote best practices; and (2) identify mechanisms at all levels through which to build shared accountability toward renewed commitment for immunization • Establish high-level plan and monitoring framework to track dimensions of commitment and facilitate continued learning • Carry out a rapid gap mapping to assess current activities and guidance available on demand and to identify any unmet needs or areas of activity • Establish a joint plan with the Vaccination Demand Hub for a desk review and annual documentation of learning, successes and best practices • Launch crowd-sourced initiative to generate “bottom-up” inputs and facilitate a workshop on accountability mechanisms to identify examples of implementation and explore potential opportunities for testing in the area of demand SP3: Coverage and equity WHO/UNICEF • Prepare briefing package • Organize webinar series/consultations • Develop coverage and equity analysis tool • Develop immunization programme resources database SP4: Life course and integration Center for Disease Control and Prevention (CDC) • Contribute to regional guidance and recommendations on the life course and integration approach and support regions ready to develop action plans • Increase awareness of key focus areas, particularly around missed opportunities for vaccination, delivery approaches and policy needs • Conduct seminars and participate in existing workshops to disseminate SP4 objectives. • Contribute to generating evidence on barriers and facilitators of the life course and integration strategy, particularly using COVID-19 vaccine roll-out as an opportunity to further this agenda • Generate research agenda for reaching life course and integration objectives, map the evidence gaps and support existing research efforts Annex 4 EB150/11 11 Focus area Lead partner Key deliverables planned 2021–2022 SP5a: Emergencies International Federation of Red Cross and Red Crescent Societies (IFRC) • Support rapid and equitable COVID-19 vaccine roll-out and scale-up in humanitarian settings (including the COVAX Facility Humanitarian Buffer, working with the Global Health Cluster) • Produce theory of change on reducing the numbers of zero-dose children in fragile and conflict settings • Support mapping of zero-dose communities in priority countries and identify drivers to guide investments at subnational levels • Facilitate sharing and peer-to-peer learning across the COVID-19 vaccine implementation plans of all regions through workshops on lessons learned in fragile, conflict and vulnerable settings SP5b: Outbreaks WHO Working group being formed SP6a: Supply security UNICEF • Track supply of essential vaccines, given potential COVID-19 disruptions • Vaccine forecasting, procurement and supply: Improve global supply, work across partners on national-level forecasting • Ensure that the supply of, and access to, new vaccines meet country needs and that vaccines are introduced in a timely manner – particularly in light of COVID-19 impact • Middle-income countries (MICS): COVAX Facility experience with MICS is providing opportunities to improve options SP6b: Financial sustainability World Bank • Share information on ongoing work related to sustainable financing; identify and prioritize gaps; stimulate work to address gaps; identify 1–2 priority reports or guidance that working groups could collectively produce • Work to improve data quality and comprehensiveness in monitoring and evaluation indicators • Through consultative engagements, bring in views of countries, regions, civil society organizations, the private sector and donors to inform policy recommendations and advise global partners SP7: Research and innovation PATH (PATH Health Tech Program) • Accelerate and expand the COVAX Facility research and development agenda for variant targeting and programmatically optimized vaccines • Support low- and middle-income countries in expanding, strengthening and/or establishing local and regional capacities for immunization research and innovation • Develop mechanism to align country-, regional- and global-level stakeholders on priority diseases for which new vaccines are needed • Establish 2025 and 2030 Immunization Agenda 2030 SP7 working group objectives to sustain progress, based on country-led research and development priorities Middle-income countries WHO • Update middle-income countries’ partner landscape • Identify opportunities to input into normative guidance • Identify and initiate priority interventions based on existing analysis • Engage regional middle-income countries’ initiatives Data strengthening and use WHO • Provide guidance to WHO/UNICEF on upcoming Gavi, the Vaccine Alliance funding request • Organize “year 0” initial priority-setting meeting • Begin implementation of initial three-year priority investments and alignment with funding • Organize quarterly progress check and alignment meetings Measles and rubella Measles and Rubella Initiative Working group being formed Disease-specific initiatives UNICEF Working group being formed EB150/11 Annex 4 12 = = = Focus area Lead partner Key deliverables planned 2021–2022 Monitoring and evaluation CDC • Develop process for technical progress reporting by indicator owners/champions • Support development of annual Immunization Agenda 2030 technical report, including regional and country engagement • If requested, support regions in the development of regional monitoring and evaluation frameworks • Provide guidance and support to the Immunization Agenda 2030 Coordination Group and Immunization Agenda 2030 Partnership Council to further improve and make periodic revisions to the Immunization Agenda 2030 monitoring and evaluation framework. Communications and advocacy WHO/UNICEF/ United Nations Foundation • Mobilize Immunization Agenda 2030 partners for action around annual data release • Engage religious leaders on Immunization Agenda 2030 • Engage parliamentarians on Immunization Agenda 2030, targeting annual Inter-Parliamentary Union conference • Plan communications around September “champions” event • Begin regional outreach and content development Resource mobilization TBD TBD SEVENTY-FIFTH WORLD HEALTH ASSEMBLY WHA75.13 Agenda item 14.6 28 May 2022 Global strategy on infection prevention and control The Seventy-fifth World Health Assembly, Having considered the consolidated report by the Director-General;1 Recalling resolutions WHA48.7 (1995) on revision and updating of the International Health Regulations, WHA58.27 (2005) on improving the containment of antimicrobial resistance, WHA69.1 (2016) on strengthening essential public health functions in support of the achievement of universal health coverage, WHA70.7 (2017) on improving the prevention, diagnosis and clinical management of sepsis, WHA72.6 (2019) on global action on patient safety, WHA72.7 (2019) on water, sanitation and hygiene in health care facilities, WHA73.1 (2020) on the COVID-19 response, WHA73.8 (2020) on strengthening preparedness for health emergencies: implementation of the International Health Regulations (2005) and WHA74.7 (2021) on strengthening WHO preparedness for and response to health emergencies, within which infection prevention and control is a critical component; Reaffirming the 2030 Agenda for Sustainable Development and its targets, which are universal, indivisible and interlinked, and referring in particular to the following targets of the Sustainable Development Goals: 3.1 on reducing global maternal mortality, 3.2 on ending preventable deaths of newborns and children under 5 years of age, 3.3 on ending the epidemics of AIDS, tuberculosis, malaria and neglected tropical diseases and combating hepatitis, waterborne diseases and other communicable diseases, and 3.8 on achieving universal health coverage, including access to quality essential health care services and access to safe, effective, quality and affordable essential medicines and vaccines for all, and recognizing the important intersections between infection prevention and control and other Sustainable Development Goals, including Goal 6 (Ensure availability and sustainable management of water and sanitation for all); Noting the Declaration of Alma-Ata2 on primary health care and the Declaration of Astana3 on high-quality and safe primary health care and health services and recognizing that to achieve it, preventing harm from infection transmission at the entry point to and at all points in the health system is paramount; Recognizing the critical importance of infection prevention and control in the human and animal health sectors and that it is a clinical and public health discipline based on a scientific approach, providing proactive, responsive and practical preventive and control measures grounded in infectious 1 Document A75/10 Rev.1. 2 Primary health care: report of the International Conference on Primary Health Care, Alma-Ata, USSR, 6-12 September 1978. Geneva: World Health Organization; 1978 (https://apps.who.int/iris/handle/10665/39228). 3 Declaration of Astana: Global Conference on Primary Health Care, Astana, Kazakhstan, 25 and 26 October 2018. Geneva: World Health Organization; 2019 (https://apps.who.int/iris/handle/10665/328123). WHA75.13 2 diseases, epidemiology, social, engineering and implementation science, and health systems strengthening that requires a dedicated specialist health work force; Noting that comprehensive infection prevention and control programmes, which take the One Health approach into account, at national, subnational and facility levels are essential to produce science-based evidence and support, facilitate and/or oversee the correct, evidence-based and risk-informed implementation of infection prevention and control, as well as the resources and material support required (such as personal protective equipment); Concerned that the COVID-19 pandemic and the recent large outbreaks of Ebola virus disease in West Africa and the Democratic Republic of the Congo have shown the devastating consequences of the lack of preparedness and substandard, insufficient and/or inadequate implementation of infection prevention and control programmes, even in high-income countries, and have brought infection prevention and control to the forefront; Recognizing that in addition to outbreaks, at any point in time1 of every 100 patients, seven in high-income countries and 15 in low- and middle-income countries acquire at least one health care-associated infection during their stay in acute-care hospitals, and a quarter of health care facilities lacked basic water services in 2019, exposing 1.8 billion people, including health care workers and patients, to greater risk of infections,2 highlighting the major gaps in water, sanitation and hygiene services in health care facilities, which play a critical role in infection prevention and control, and noting the modest costs for achieving minimal water, sanitation and hygiene safety, which range from US$ 6.5 billion to US$ 9.6 billion in the 46 least developed countries, which represent 4–6% of these countries’ recurrent health spending; Although no precise analysis is possible due to lack of comprehensive data, noting that WHO has estimated that hundreds of millions of patients are affected by health care-associated infections leading to deaths in one in 10 infected patients every year, and noting further that in acute-care hospitals, of every 100 patients, seven in high-income countries and 15 in low- and middle-income countries will acquire at least one health care-associated infection during their hospital stay, and that up to 30% of patients in intensive care are affected by health care-associated infections, with an incidence that is two to 20 times higher in low- and middle-income countries than in high-income countries;3 Noting the added costs of health care-associated infections, which may vary from US$ 1000 to US$ 12 000 on average per episode depending on the country,4 result in a significant economic burden on health systems and out-of-pocket expenses for patients and families; and that the mortality among patients affected by health care-associated sepsis was 24.4%, increasing up to 52.3% among patients 1 Allegranzi B, Bagheri Nejad S, Combescure C, Graafmans W, Attar H, Donaldson L, et al. Burden of endemic health-care-associated infection in developing countries: systematic review and meta-analysis. Lancet. 2011 Jan 15:377(9761):228-41. doi: 10.1016/S0140-6736(10)61458-4. 2 WHO and UNICEF. (2020). Global progress report on water, sanitation and hygiene in health care facilities: fundamentals first. Geneva: World Health Organization; 2020. (https://apps.who.int/iris/handle/10665/337604). 3 Global report on the epidemiology and burden of sepsis: current evidence, identifying gaps and future directions. Geneva: World Health Organization; 2020 (https://apps.who.int/iris/handle/10665/334216). 4 Forrester JD, Maggio PM, Tennakoon L. Cost of health care-associated infections in the United States. J Patient Saf. 2022 Mar 1;18(2):e477-e479. doi: 10.1097/PTS.0000000000000845. WHA75.13 3 treated in an intensive care unit and at least two to three times higher among those infected with antimicrobial-resistant organisms, in neonates and in low- and middle-income countries;1 Noting that most antibiotic-resistant infections are acquired in health care facilities, 75% of disability-adjusted life years attributable to antimicrobial resistance are due to health care-associated infections.2 Each year, antimicrobial resistance costs health care systems around US$ 1.2 billion. For example, up to 75% of prescriptions for antimicrobial medicines in long-term care facilities are inappropriate, yet policies to tackle inappropriate antimicrobial use and antimicrobial resistance, such as antimicrobial stewardship and infection prevention and control, remain underused or suboptimal;3 Noting that a recent systematic analysis and predictive statistical models by antimicrobial resistance collaborators showed that in 2019 the estimated number of deaths associated with bacterial antimicrobial resistance was 4.95 million (95% uncertainty interval: 3.62–6.57) globally, including 1.27 million (95% uncertainty interval: 0.911–1.71) deaths attributable to bacterial antimicrobial resistance and reflect the burden of antimicrobial resistance as a leading cause of death globally, with a high impact in low-resource settings;4 Observing that most cost-effective interventions to limit the spread of antimicrobial resistance in health care are those aimed at improving all hospital-associated drivers, including hygiene and antimicrobial stewardship, with the potential to prevent three of four attributable deaths;5 Noting that public health emergencies have demonstrated that infection prevention and control, together with core capacities required by the International Health Regulations (2005), play a critical role in preventing and responding timely and effectively to public health risks and emergencies of national and international concern; Recognizing that the COVID-19 pandemic has also demonstrated the critical role of health system resiliency in providing essential health services and maintaining functional health systems and that the cornerstone of health system resiliency is keeping health care workers, patients and visitors safe through a series of measures, including infection prevention and control, best practices and essential infrastructure, including transmission-based precautions and water, sanitation and waste management wherever health care is provided; 1 Markwart R, Saito H, Harder T, Tomczyk S, Cassini A, Fleischmann-Struzek C, et al. Epidemiology and burden of sepsis acquired in hospitals and intensive care units: a systematic review and meta-analysis. Intensive Care Med. 2020 Aug;46(8):1536-1551. doi: 10.1007/s00134-020-06106-2. 2 Cassini A, Högberg LD, Plachouras D, Quattrocchi A, Hoxha A, Simonsen GS, et al.. Attributable deaths and disability-adjusted life-years caused by infections with antibiotic-resistant bacteria in the EU and the European Economic Area in 2015: a population-level modelling analysis. Lancet Infect Dis. 2019 Jan;19(1):56-66. doi: 10.1016/S1473- 3099(18)30605-4. 3 Eze N, Cecchini M, Oliveira Hashiguchi T. Antimicrobial resistance in long-term care facilities. OECD Health Working Papers, No. 136. Paris: OECD Publishing; 2022, https://doi.org/10.1787/e450a835-en. 4 Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet. 2022 Feb 12;399(10325):629-655. doi: 10.1016/S0140-6736(21)02724-0. 5 European Centre for Disease Control and Prevention and OECD. Antimicrobial resistance. Tackling the burden in the European Union. Briefing note for EU/EAA countries. 2019. (https://www.oecd.org/health/health-systems/AMR- Tackling-the-Burden-in-the-EU-OECD-ECDC-Briefing-Note-2019.pdf). WHA75.13 4 Recognizing the unique opportunity to harness the experience of the heightened global awareness of infection prevention and control and investments made during the COVID-19 pandemic for sustained improvements in infection prevention and control, 1. CALLS ON Member States:1 (1) to take steps to support and/or to ensure that infection prevention and control is one of the key components of global health preparedness, prevention and response; (2) to acknowledge that clean, high-quality, safe, affordable care should be universally available and that no one should be unnecessarily exposed to infection due to suboptimal infection prevention and control practices; (3) to take steps to support and/or to ensure that science-based functional infection prevention and control programmes exist – for both community-acquired and health care-associated infections, taking into account the One Health approach – are implemented, monitored and updated at national, subnational, and/or facility levels, as appropriate to national contexts and in line with the WHO core components of such programmes;2 (4) to take steps to support relevant authorities and/or ensure that at least the minimum requirements for infection prevention and control programmes at the national, subnational and health care facility levels are implemented and monitored, inclusive of environmentally conscious and appropriate waste management to reduce further impact on human, animal and environmental health; (5) to support and ensure that transmission-based precautions for infection prevention and control are implemented with fidelity and quality at national and facility levels, and functional administrative, environmental and personal protection measures are in place to prevent and/or halt further transmission; (6) to take steps to support and/or to ensure that sustainable infection prevention and control and water, sanitation and hygiene infrastructures and resources are in place and utilized across all health care facilities, including in primary health care, home and community-based settings, and long-term care settings as appropriate to the national context; (7) to take steps to recognize the value of having infection prevention and control professionals across a variety of settings, with appropriate competencies, skills, career pathways and empowerment with a clear mandate and authority, while being held accountable, and who work within the clinical governance framework of their organizations for implementation and reporting the impact of infection prevention and control programmes as appropriate to the national context; (8) to take steps toward creating and implementing accredited infection prevention and control curricula within pre-graduate, post-graduate and in-service continuous education, where and as appropriate in national contexts, for all health care workers and all relevant disciplines; 1 And, where applicable, regional economic integration organizations. 2 Guidelines on core components of infection prevention and control programmes at the national and acute health care facility level. Geneva: World Health Organization; 2016 (https://apps.who.int/iris/handle/10665/251730). WHA75.13 5 (9) to take steps to ensure that infection prevention and control programmes are integrated and aligned with programmes on antimicrobial resistance, quality of care, patient safety, water, sanitation and hygiene, construction and remodelling of the infrastructure of health care facilities, and health emergencies programmes, as well as programmes on bloodborne infectious diseases, tuberculosis, acute respiratory infections, vaccine-preventable diseases, neglected tropical diseases, occupational health, sexual and reproductive health, and maternal, neonatal and child health, and other relevant programmes where and as appropriate for national contexts; (10) to provide decisive and visible political commitment and leadership engagement at the highest levels to sustain and improve implementation of functional infection prevention and control programmes at the regional, national, local and facility levels, including encouraging allocation of national and local dedicated budgets where and as appropriate and guided by domestic context; (11) to introduce guidance, regulations and/or legal frameworks to enforce infection prevention and control requirements, polices and implementation of best practices through systems for accrediting health facilities and other mechanisms, as appropriate and guided by domestic context; (12) to undertake as appropriate to national contexts, regular, detailed and multilevel assessments of infection prevention and control programmes, practices and surveillance of health care-associated infections and antimicrobial resistance in order to generate and share data to be used for action and improving outcomes; (13) to continue to encourage investments in research on infection prevention and control; 2. REQUESTS the Director-General: (1) to develop, in consultation with Member States and regional economic integration organizations, a draft global strategy – in alignment with other strategies on infection prevention and control efforts, such as the global action plan on antimicrobial resistance – on infection prevention and control in both health and long-term care settings, for consideration by the Seventy-sixth World Health Assembly in 2023, through the Executive Board at its 152nd session; (2) to translate the global strategy on infection prevention and control in both health and long- term care settings into an action plan for infection prevention and control, including a framework for tracking progress, with clear measurable targets to be achieved by 2030, for consideration by the Seventy-seventh World Health Assembly in 2024, through the Executive Board at its 154th session; (3) to continue to update and develop as required technical guidance on infection prevention and control programmes and practices for health and long-term care settings; (4) to report on progress and results to the Seventy-eighth World Health Assembly in 2025, and thereafter every two years until 2031. Eighth plenary meeting, 28 May 2022 A75/VR/8 = = = EXECUTIVE BOARD EB150/12 150th session 10 January 2022 Provisional agenda item 12 Infection prevention and control Report by the Director-General BACKGROUND 1. This report outlines the impact caused by the spread of infection and antimicrobial resistance acquired in health care facilities, the global situation of infection prevention and control programmes at the national and facility levels, as well as gaps and challenges in implementation of infection prevention and control. It also provides an overview of WHO’s recent activities on infection prevention and control and proposes some priorities and actions aimed at improving implementation of infection prevention and control programmes. BURDEN AND IMPACT OF INFECTIONS, SEPSIS AND ANTIMICROBIAL RESISTANCE ACQUIRED IN HEALTH CARE 2. Over the past decade, the Secretariat and other agencies have demonstrated the significant global burden of health care-associated infections, many of which are caused by multidrug-resistant organisms and/or can cause outbreaks in health care facilities and in community settings. In acute care hospitals, out of every 100 patients, 7 in high-income countries and 15 in low- and middle-income countries will acquire at least one health care-associated infection during their hospital stay. Among intensive care patients, the incidence of health care-associated infections is 2 to 20 times higher in low- and middle- income countries than in high-income countries. Although no precise analysis is possible due to lack of comprehensive data, WHO has estimated that hundreds of millions of patients are affected by health care-associated infections leading to death in 1 in 10 infected patients every year. The coronavirus disease (COVID-19) pandemic has demonstrated how critical infection prevention and control is to maintaining essential health services and ensuring patient and health worker safety. 3. In most cases, both health care-associated infections and the spread of antimicrobial resistance in health care settings are a consequence of poor-quality care delivery and inadequate health infrastructure combined with inexistent or defective infection prevention and control programmes. In particular, key determinants are low compliance with hand hygiene and aseptic technique practices, contaminated medical equipment and supplies, inadequate environmental cleaning, lack of trained infection prevention and control professionals and limited opportunities for staff training, exceeded bed occupancy, understaffing and limited or suboptimal infrastructure for patient isolation. 4. In the European Union and European Economic Area, up to 8.9 million health care-associated infections occur every year in acute and long-term care facilities; a population-based modelling study estimated that the six most common health care-associated infections generate almost twice the total burden of disability-adjusted life years of all other 32 communicable diseases combined. In the European Union and European Economic Area, antibiotic-resistant microorganisms are responsible for most EB150/12 2 infections and 75% of disability-adjusted life years attributable to antimicrobial resistance are due to health care-associated infections. 5. Obstetric infections are the third most frequent cause of maternal sepsis, which is responsible for 10.7% of maternal deaths. Almost all maternal deaths due to obstetric infections occur in low- and middle-income countries. Caesarean section is the single most important risk factor for maternal infection after childbirth. 6. Severe neonatal infections, including neonatal sepsis, represent a significant cause of neonatal mortality and long-term morbidity. The highest neonatal sepsis incidence rates are in low- and middle- income countries, particularly in the WHO African Region. The survival of preterm, small (low birthweight) and sick infants has improved over time. However, such infants often require hospital care, which exposes them to the risk of hospital-acquired infections and late-onset sepsis. Newborns in developing countries are at higher risk of acquiring health care-associated infections, with infection rates 3 to 20 times higher than in high-income countries. 7. Several studies during the continuing COVID-19 pandemic have reported severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections acquired by patients in health care settings, ranging from 0% to 41% of inpatients. Among health workers, the prevalence of SARS-CoV-2 seropositivity has ranged between 0.3% and 39.6% and the incidence of infection has varied from 0.4% to 49.6%; however, huge variations over time and by country have been observed and it is very difficult to distinguish between community- and health care-acquired infections. According to the WHO global surveillance database (the WHO coronavirus (COVID-19) dashboard), COVID-19 cases among health workers slightly exceeded 10% in the first wave of the pandemic in March 2020, decreased to less than 5% by early June 2020 and further decreased to 2.5% by September 2020, suggesting that improvements in implementation of infection prevention and control made after the initial spread of the virus may have contributed to reducing health workers’ exposure. OPPORTUNITIES: HOW INFECTION PREVENTION AND CONTROL CAN CONTRIBUTE TO ACHIEVING SAFE CARE DELIVERY AND HEALTH SECURITY 8. Infection prevention and control is a clinical and public health specialty that is based on a scientific approach, providing practical solutions grounded in infectious diseases, epidemiology, social and implementation science, and health systems strengthening. It is designed to prevent harm due to infection to patients, health workers and visitors in health care settings. 9. Infection prevention and control programmes at national, subnational and facility levels are essential to oversee the correct, evidence-based implementation of infection prevention and control and the resources and material support (such as, personal protective equipment) required. It should be noted, however, that correct use of personal protective equipment is just one small component of a comprehensive package of infection prevention and control measures and within an overall infection prevention and control programme responsible for training, oversight and monitoring to prevent the transmission of infectious agents in health care settings. 10. The COVID-19 pandemic, as well as other large-scale health emergencies, have demonstrated that infection prevention and control, together with other core capacities required by the International Health Regulations (2005), plays a critical role in detecting, assessing, notifying and reporting events, and responding to public health risks and emergencies of national and international concern. The pandemic has also demonstrated the critical role of health system resiliency in providing essential health EB150/12 3 services and maintaining health systems functioning. The cornerstone of health system resiliency is keeping health workers, patients and visitors safe through a series of measures, including infection prevention and control best practices. 11. Evidence-based infection prevention and control interventions have been shown to be effective in preventing 35–70% of health care-associated infections, and having an active infection prevention and control programme can reduce health care-associated infections by 30%. Whether implemented as a standalone intervention or integrated into multifaceted interventions, hand hygiene has been highlighted as the most critical and proven measure in reducing transmission of microorganisms and lowering the incidence of health care-associated infections in health care settings. 12. A report by OECD showed that the most cost-saving interventions to limit the spread of antimicrobial resistance in health care were those aimed at improving hospital hygiene and antimicrobial stewardship, with the potential to prevent three out of four attributable deaths.1 It also showed that the increasing availability of infection prevention and control equipment and infrastructure (such as alcohol- based handrubs) at the point of care and isolation beds are associated with a proportionate reduction of the most common patterns of antimicrobial resistance that are associated with health care. 13. Implementation and monitoring of infection prevention and control programmes contribute to meeting targets of the Sustainable Development Goals (3.1, 3.2, 3.3 and 3.8, and those of Goal 6), as well as to reducing the indicator 3.d.2 concerning antimicrobial resistance. Infection prevention and control is also recommended as critical interventions in several Health Assembly resolutions. Infection prevention and control is a practical and evidence-based approach with demonstrated impact on quality of care and patient safety across all levels of the health system: it is therefore paramount to achieve quality care for all (resolution WHA69.1 (2016)). Furthermore, strategy 3.3 of the global patient safety action plan 2021–2030 focuses on infection prevention and control (resolution WHA72.6 (2019)). Infection prevention and control is also at the core of objective 3 of the global action plan on antimicrobial resistance because it reduces both the spread of antimicrobial-resistant organisms and the occurrence of infection and thus the need for antimicrobials use, which then has an impact on the emergence of antimicrobial resistance (resolution WHA58.27 (2005)). The existence of strong infection prevention and control programmes and capacity constitutes the foundation of adequate preparedness and response to outbreaks, and thus is key for the prevention of health emergencies, including fulfilment of the International Health Regulations (2005) (resolutions WHA48.7 (1995), WHA73.1 (2020), WHA73.8 (2020), WHA74.7 (2021)). Infection prevention and control is complementary to water, sanitation and hygiene efforts (resolution WHA72.7 (2019)) and provides implementation approaches for achieving behavioural change among health workers and people in the community. Lastly, embedding infection prevention and control practices within maternal and neonatal care pathways contributes to improving maternal and neonatal health given that sepsis is a major cause of morbidity and mortality (including health care-associated morbidity and mortality) in these fragile populations (resolution WHA70.7 (2017)). 14. On the basis of scientific evidence, expert consensus and country experience, and with the support of many international partners, in 2016 WHO issued recommendations on the core components of effective infection prevention and control programmes for the national and acute care health facility 1 Stemming the superbug tide: just a few dollars more. Paris: Organisation for Economic Co-operation and Development; 2018 (https://doi.org/10.1787/9789264307599-en, accessed 23 November 2021). EB150/12 4 levels.1 A comprehensive package of implementation and monitoring resources accompanied the issue of these WHO guidelines. In 2019, WHO further specified the minimum requirements for infection prevention and control programmes, with the aim of supporting stepwise implementation towards full achievement of the requirements of the infection prevention and control core components.2 15. WHO regional offices have set up cross-cutting teams to support implementation of infection prevention and control programmes and contribute to a number of health priorities in an integrated manner. Country offices make considerable efforts to provide support for infection prevention and control; however, this is often hampered by the burden of other competing priorities and the availability of human resources and limited technical expertise. CHALLENGES IN IMPLEMENTATION OF INFECTION PREVENTION AND CONTROL 16. Despite the demonstrated impact of infection prevention and control, countries struggle to prioritize, invest in, establish and implement the core components of infection prevention and control programmes, even their minimum requirements. 17. Indeed, according to the annual tripartite antimicrobial resistance country self-assessment survey in 2020–2021, 33% of countries surveyed reported having no national infection prevention and control programme or the programme had not been implemented. Conversely, in only 37% of countries had infection prevention and control programmes been correctly implemented and monitored in health care facilities nationwide. Compared with low-income countries, high-income countries were 8.29 times more likely to have a more advanced infection prevention and control implementation status. According to a WHO global survey carried out in 2019, only 15.7% of health care facilities met all WHO infection prevention and control minimum requirements, ranging from 0% in low-income countries to 27.4% of primary and 10.7% of secondary and tertiary health care facilities in high-income countries. Although high-income countries have better established infection prevention and control programmes, the COVID-19 pandemic has shown that even the wealthiest countries have to build more resilient health care systems with effective infection prevention and control to avoid or mitigate the impact of outbreaks. 18. A significant gap in implementation is the critical problem. A WHO global survey in 2018 at the national level demonstrated that while national guidelines on infection prevention and control practices existed in 50% of low-income countries and 69–77% of middle- and high-income countries, only 20% of low-income countries and 29–57% of middle- and high-income countries had implementation plans and strategies. Overall, only 22% of all countries monitored implementation roll-out and impact. In this survey, only 26% of countries reported having a dedicated budget for infection prevention and control supported by the national authorities; of these, most were high-income countries (65%); only one was a low-income country. 19. At the facility level, a WHO global survey in 2019 showed that the core components related to the built environment, materials and equipment for infection prevention and control and guidelines on infection prevention and control were best implemented, whereas those related to workload, staffing and bed occupancy, and infection prevention and control education and training, were the most defective. 1 Guidelines on core components of infection prevention and control programmes at the national and acute health care facility level. Geneva: World Health Organization; 2016 (https://apps.who.int/iris/handle/10665/251730, accessed 24 November 2021). 2 Minimum requirements for infection prevention and control programmes. Geneva: World Health Organization; 2019 (https://apps.who.int/iris/handle/10665/330080, accessed 24 November 2021). EB150/12 5 Among low-income countries, surveillance and monitoring of health care-associated infections, and audit of infection prevention and control practices and feedback, were the least implemented. Similar results have been reported recently by WHO regional offices with the exception that countries are progressing in establishing infection prevention and control programmes and developing national infection prevention and control guidelines. 20. Low-income countries in particular struggle to have an appropriate built environment to support infection prevention and control programmes and clean care delivery. In 2020, WHO reported that one in four health care facilities worldwide do not have basic water services and one in three lack hand hygiene supplies at the point of care, with alcohol-based handrubs continuously available in 75% of facilities in high-income countries, but in only 17% of facilities in low-income countries. 21. Over the past year, much progress has been made by building infection prevention and control minimum requirements and improving practices to fight against COVID-19; however, in a WHO pulse survey in 2020 on the impact of the COVID-19 pandemic on essential health services in low- and middle-income countries, lack of infection prevention and control supplies and best practices was identified as a major reason for service disruption (for example, interruption of routine vaccination programmes) by 44% of countries. PRIORITIES TO ADDRESS INFECTION PREVENTION AND CONTROL IN NATIONAL AND INTERNATIONAL HEALTH AGENDAS 22. All countries should acknowledge that clean, high-quality, safe care should be universally available to every person worldwide. No one, health workers in particular, should be unnecessarily exposed to infection during health care delivery due to suboptimal infection prevention and control practices, or lack of personal protective equipment or of available vaccines. 23. The COVID-19 pandemic and the recent large outbreaks of Ebola virus disease in West Africa and the Democratic Republic of the Congo have shown the devastating consequences of a lack of preparedness and defective infection prevention and control programmes, even in high-income countries, and have brought infection prevention and control to the forefront. Infection prevention and control should be a central component of pandemic and global health security planning in all countries. 24. In order to achieve the Sustainable Development Goals and implement the Health Assembly resolutions cited in paragraph 13, countries should ensure that functional infection prevention and control programmes exist at the national and facility levels, according to the WHO core components of such programmes,1 and that sustainable infection prevention and control and water, sanitation and hygiene infrastructures and resources are in place in all health care facilities, including in primary care. Despite the huge efforts made globally to enhance infection prevention and control interventions in the past decade, and especially during the COVID-19 pandemic, sustainability is at risk as the newly built infection prevention and control programmes and water, sanitation and hygiene infrastructures could be progressively dismantled, and the attention and resources dedicated to infection prevention and control are likely to decrease as soon as the pandemic is over. 25. At least the minimum requirements for infection prevention and control programmes at the national and health care facility level should be in place in all countries, and their implementation 1 Guidelines on core components of infection prevention and control programmes at the national and acute health care facility level. Geneva: World Health Organization; 2016 (https://apps.who.int/iris/handle/10665/251730, accessed 24 November 2021). EB150/12 6 demonstrated by monitoring key indicators for infection prevention and control and water, sanitation and hygiene in the context of the infection prevention and control core components, the International Health Regulations (2005) and the WHO/UNICEF Joint Monitoring Programme for Water Supply, Sanitation and Hygiene. It should be noted that fulfilling the minimum requirements for infection prevention and control has become an essential parameter to be met within the 2021 edition of the State Party self-assessment annual reporting and the joint external evaluation tools. 26. While the existence of specific infection prevention and control programmes supported by dedicated trained infection prevention and control professionals is paramount, infection prevention and control activities must be integrated and aligned with those related to antimicrobial resistance, quality of care, patient safety, water, sanitation and hygiene, and health emergencies programmes, as well as HIV, tuberculosis, malaria, and maternal and child health, and other programmes, in order to emphasize the horizontal nature of infection prevention and control and to avoid duplication or vertical implementation. In particular, efforts to improve infection prevention and control practices should be contextualized within quality improvement and the spirit of the safety climate by which all facilities should be pervaded. 27. Decisive and visible political commitment and leadership engagement at the highest levels are needed to sustain and improve implementation of functional infection prevention and control programmes at the national and facility levels, including considering infection prevention and control as a priority for allocation of national and local health budgets. Member States, the Secretariat and global partners should identify targets for infection prevention and control investment, based on a percentage of overall health care expenditure, that is a reasonable amount to commit for safe and clean provision of care. Progress made towards achieving these targets should be publicly available. 28. Regulations and legal frameworks are needed to enforce infection prevention and control requirements and policies through systems for accrediting health facilities and other mechanisms for accountability agreed on at international level and adapted locally. These mechanisms should enforce, among other things, key infrastructural minimum requirements such as those pertaining to overcrowding, understaffing and the built environment including water, sanitation and hygiene. 29. The infection prevention and control core components cannot be implemented without competent infection prevention and control professionals and frontline health workers understanding infection prevention and control principles and practices. Thus, creation and implementation of accredited infection prevention and control curricula within pre-graduate health courses and in-service continuous education is essential. Similarly, infection prevention and control post-graduate curricula and courses are needed to create local infection prevention and control expertise; the WHO infection prevention and control core competencies can be used as a template.1 Furthermore, the lack of human resources dedicated to infection prevention and control as well as adequate health care staffing at the facility level should be urgently tackled in countries, given that their adequate numbers and ratios with patient beds have been demonstrated to correlate with prevention of health care-associated infections and spread of antimicrobial resistance, in particular during outbreaks. Infection prevention and control professionals should be offered a recognized career pathway and empowered with a clear mandate and authority, while being held accountable for implementation and reporting the impact of infection prevention and control programmes. Inclusion of infection prevention and control professionals into the structure of executive 1 Core competencies for infection prevention and control professionals. Geneva: World Health Organization; 2020 (https://apps.who.int/iris/handle/10665/335821, accessed 24 November 2021). EB150/12 7 hospital boards and senior management will ensure that infection prevention and control and water, sanitation and hygiene are prioritized. 30. Establishing the local epidemiology of health care-associated infections and promptly detecting epidemic- and pandemic-prone and emerging antimicrobial-resistant microorganisms are critical functions to tackle patient harm and health worker infection risks. Thus, functioning and quality- controlled systems for surveillance of health care-associated infections and antimicrobial resistance should be established, in line with the Global Antimicrobial Resistance and Use Surveillance System and other standardized surveillance systems for health care-associated infections and antimicrobial resistance (such as the ones coordinated by the European Centre for Disease Prevention and Control). Good-quality laboratory diagnostics and services are critical to enable identification of pathogens and inform surveillance of antimicrobial resistance, health care-associated infections and early detection of outbreaks. 31. High-level data on infection prevention and control (such as the existence of an infection prevention and control programme) are monitored by most countries through regular surveys coordinated by WHO and partners. However, they often do not reflect actual functioning, implementation and impact of infection prevention and control programmes. Thus, more detailed and multilevel assessments of such programmes should be undertaken regularly. The new WHO global infection prevention and control portal1 offers the opportunity to undertake this type of monitoring, in a protected confidential space, using standardized tools. 32. Data collection must be used for action and improving outcomes. Infection prevention and control monitoring results and surveillance data should be streamlined and used locally to identify the existing strengths and critical gaps so that targeted and feasible improvement plans can be collectively elaborated and implemented. Thus, evaluation feedback to all involved key players – from senior managers to all concerned frontline staff – should be ensured, including using modern technologies that facilitate automatic reporting and point-of-care feedback. ACTION BY THE EXECUTIVE BOARD 33. The Board is invited to note the report and provide further guidance on action that could be taken by the Organization in response to the burden of infections and antimicrobial resistance acquired in health care. = = = 1 https://ipcportal.who.int/, accessed 11 December 2021. EXECUTIVE BOARD EB150/13 150th session 3 December 2021 Provisional agenda item 13 Global road map on defeating meningitis by 2030 Report by the Director-General 1. In resolution WHA73.9 (2020) concerning the global road map on defeating meningitis by 2030, the Seventy-third World Health Assembly requested the Director-General, inter alia, to submit a report to the Executive Board at its 150th session on progress in implementing the resolution, and a report to the Seventy-sixth World Health Assembly, through the Executive Board at its 152nd session, to review the global meningitis situation and assess efforts made in meningitis prevention and control. This document provides a summary of WHO activities in that respect since November 2020. 2. As at September 2021, action had been taken to strengthen strategic leadership and coordination with partners; develop regional implementation frameworks; and prepare the monitoring and evaluation plan, business case and official launch of the global road map on defeating meningitis by 2030.1 3. The WHO Technical Taskforce on defeating meningitis by 2030, composed of partners and international experts engaged in long-term meningitis control, played an essential role in the development of the global road map and will be responsible for leading and coordinating its global and regional implementation via a forum for technical exchange and cooperation on meningitis. Membership of the Technical Taskforce may be further extended to include new institutions and new advisers, where appropriate and taking into account regional relevance. The Secretariat will regularly review the Technical Taskforce’s composition and assess whether any rotation of its members is necessary. The term of membership will be for an initial period of three years, renewable once for a further three years. 4. The Secretariat is also planning to establish a strategic support group to support WHO and its partners in the global and regional implementation of the global road map and the achievement of its objectives. The main roles and responsibilities of the members of the strategic support group will include: providing political and/or financial support for implementation and monitoring of the global road map; advocating and acting as ambassadors for meningitis prevention and control; and raising public awareness of the burden of meningitis. The strategic support group will consist of representatives from global and regional donors, ministries of health and civil society organizations who are highly committed to defeating meningitis by 2030. The Secretariat will regularly review the composition of the group and assess whether any rotation of members is necessary. The term of membership will be for an initial period of three years, renewable once for a further three years. 1 On 28 September 2021, the World Health Organization launched its first global road map to defeat meningitis by 2030: https://www.who.int/news-room/events/detail/2021/09/28/default-calendar/launch-of-the-defeating-meningitis-roadmap. (accessed 9 November 2021). EB150/13 2 5. The main activities and milestones of the global road map have been integrated into an operational workplan for 2021. An updated workplan for 2022–2023 is being finalized. Under these workplans, some key activities of the global road map have already started, including: (i) development of policies, guidelines and strategies pertaining to the prevention, treatment and detection, as well as the monitoring and management of meningitis and its sequelae; (ii) conducting of outcome-oriented research to inform policy and strategy development; (iii) improvement of the functioning and use of emergency meningitis vaccine stockpiles, including through the repurposing of unused doses for outbreak response; and (iv) strengthening of communication methods to enhance awareness of meningitis and raise its global profile on the global health agenda, including by promoting the integration of meningitis into universal health coverage and primary health care. 6. As a foundation for developing regional implementation frameworks and national meningitis action plans aligned with other related national, regional and global initiatives, the six WHO regions are conducting high-level landscape analyses of key data on meningitis burden and health services by country. The African Region has already finalized its high-level landscape analysis as well as its implementation framework, which was adopted by Member States at the seventy-first session of the Regional Committee for Africa in August 2021. 7. As an additional basis to support and integrate regional and national implementation, it is proposed that the global road map should serve as an illustrative example of how to use the primary health care levers of the operational framework for primary health care for action on meningitis. This, in turn, would help to drive efforts aimed at strengthening the integration of meningitis prevention, diagnosis, treatment and care including management of sequelae into primary health care by increasing service coverage and access to essential medicines, improving surveillance and critical research, and addressing the discrimination and stigma facing people affected by meningitis. 8. The monitoring and evaluation plan of the global road map has been drafted and is expected to be finalized by the end of 2021. The plan is based on the theory of change that underpins the global road map and includes output, outcome and impact indicators that are in line with the global road map’s objectives and goals. Since the global road map will reinforce and be integrated with wider initiatives related to strengthening primary health care and health systems, increasing immunization coverage, improving global health security, fighting antimicrobial resistance and ensuring the rights and inclusion of persons with disabilities, the monitoring and evaluation plan has been similarly devised to align with the monitoring and evaluation plans of related initiatives. 9. The drafting of the business case to support the implementation of the global road map is at an advanced stage. The objective of the business case is to promote the global road map and ensure that sufficient resources are available for its implementation at the national, regional and global levels. To this end, it makes the case for financing the road map by: (i) describing the current meningitis situation and the overall health and socioeconomic impact of meningitis on individuals, health systems and society; (ii) showing how the global road map will address current gaps in meningitis control and how it will drive change; (iii) highlighting that the global road map has far-reaching and achievable objectives; (iv) demonstrating that the global road map will bring benefits beyond meningitis; (v) estimating the financial resources necessary for the implementation of each category of activities under the global road map; and (vi) setting out the interest and value of investing in the implementation of the global road map. 10. On 28 September 2021, the Director-General officially launched the global road map via a virtual event, with the aim of increasing awareness of its provisions and strengthening the engagement of stakeholders in its implementation. With a rich, diverse and moving programme, the event addressed those personally affected by meningitis as well as country representatives, implementing EB150/13 3 partners and other stakeholders, and included contributions from meningitis advocates, donors and key technical partners. ACTION BY THE EXECUTIVE BOARD 11. The Board is invited to note the report. In its discussions, it is further invited to provide comments and guidance on the Secretariat’s proposed approach, in particular on: • the proposed establishment of a strategic support group to strengthen coordination and engagement and to raise the profile of meningitis on the global public health agenda; and • the proposed use of the primary health care levers of the operational framework for primary health care for action on meningitis, including on how to strengthen the integration of meningitis prevention and management in primary health care. = = = SEVENTY-FIFTH WORLD HEALTH ASSEMBLY WHA75(25) Agenda item 14.8 28 May 2022 Standardization of medical devices nomenclature The Seventy-fifth World Health Assembly, having considered the reports by the Director-General,1,2 and re-affirming WHO’s role in the development, in a transparent and evidence-based way, of norms, standards and a standardized glossary of definitions relating to medical devices, as requested in resolution WHA60.29 (2007), Decided to request the Director General: (1) to integrate available information related to medical devices, including terms, codes and definitions, in the web-based database and clearinghouse established in line with resolution WHA60.29 (2007) and now available as the Medical Devices Information System (MEDEVIS);3 and to link this to other WHO platforms, such as the International Classification of Diseases (ICD-11),4 to serve as a reference to stakeholders and Member States; (2) to submit a substantive report on progress made in implementing this decision to the Executive Board at its 152nd session in January 2023 and its 156th session in January 2025. Eighth plenary meeting, 28 May 2022 A75/VR/8 = = = 1 Document A75/11. 2 Document A75/11 Add.1. 3 MeDevIS is available at https://medevis.who-healthtechnologies.org/ (accessed 13 May 2022). 4 ICD-11 is available at https://www.who.int/standards/classifications/classification-of-diseases (accessed 13 May 2022). SEVENTY-FIFTH WORLD HEALTH ASSEMBLY WHA75(9) Agenda item 16.2 27 May 2022 Strengthening WHO preparedness for and response to health emergencies The Seventy-fifth World Health Assembly, having considered the report of the Member States Working Group on Strengthening WHO Preparedness and Response to Health Emergencies,1 Decided: (1) to welcome the report; (2) with respect to targeted amendments to the International Health Regulations (2005): (a) to continue the Working Group on Strengthening WHO Preparedness and Response to Health Emergencies, with a revised mandate, including as appropriate and if agreed within each region, the rotation of the Bureau, and name (the “Working Group on Amendments to the International Health Regulations (2005)” (WGIHR)) to work exclusively on consideration of proposed targeted amendments to the International Health Regulations (2005), consistent with decision EB150(3) (2022), for consideration by the Seventy-seventh World Health Assembly in 2024; (b) to request the Director-General to convene a Review Committee on the International Health Regulations (2005) (IHR Review Committee), as early as possible but no later than 1 October 2022, in accordance with Part IX, Chapter III, of the International Health Regulations (2005), in particular Article 50, paragraphs 1(a) and 6, with particular attention to be paid to the fulfilment of the letter and spirit of Article 51, paragraph 2, to make technical recommendations on the proposed amendments referred to in subparagraph (c) below, with a view to informing the work of the WGIHR; (c) to invite proposed amendments to be submitted by 30 September 2022, with all such proposed amendments being communicated by the Director-General to all States Parties without delay; (d) to request the WGIHR to convene its organizational meeting no later than 15 November 2022, and to coordinate with the process of the Intergovernmental Negotiating Body (INB) to draft and negotiate a WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response, including through regular coordination between the two Bureaus and alignment of meeting schedules and workplans, as both the International Health Regulations (2005) and the new instrument are expected to play central roles in pandemic prevention, preparedness and response in the future; 1 Document A75/17. WHA75(9) 2 (e) to request that the IHR Review Committee submit its report to the Director-General no later than 15 January 2023, with the Director-General communicating it without delay to the WGIHR; (f) to request the WGIHR to establish a programme of work, consistent with decision EB150(3), and taking into consideration the report of the IHR Review Committee, to propose a package of targeted amendments, for consideration by the Seventy-seventh World Health Assembly, in accordance with Article 55 of the International Health Regulations (2005); (3) to encourage Member States to continue to review and consider the possible actions contained in Appendix 3 of document A75/17, in relation to health emergency prevention, preparedness and response, including through relevant ongoing WHO governing bodies processes, while noting that those possible actions are complementary and additional to existing mandates already under implementation by the Secretariat; (4) to request the Director-General: (a) to submit a report to the Seventy-sixth World Health Assembly, under a substantive agenda item, on: (i) the Secretariat’s progress to implement actions that have been previously mandated by WHO’s governing bodies and that are related to the activities mentioned in paragraph 3, in accordance with existing reporting requirements; (ii) as appropriate, views from the WHO Secretariat on possible modalities for carrying forward the activities mentioned in paragraph 3 that are not presently under implementation; (b) to support the WGIHR, by: (i) convening its first meeting no later than 15 November 2022, and subsequent meetings at the request of the co-chairs as frequently as necessary; (ii) providing the WGIHR with the necessary services and facilities for the performance of its work, and complete, relevant and timely information and advice. Seventh plenary meeting, 27 May 2022 A75/VR/7 = = = SEVENTY-FIFTH WORLD HEALTH ASSEMBLY WHA75.8 Agenda item 16.2 27 May 2022 Strengthening clinical trials1 to provide high-quality evidence on health interventions and to improve research quality and coordination The Seventy-fifth World Health Assembly, Recalling resolutions WHA58.34 (2005) acknowledging that high-quality, ethical research and the generation and application of knowledge are critical in achieving internationally agreed health-related development goals, WHA63.21 (2010) outlining WHO’s role and responsibilities in health research, WHA66.22 (2013) and WHA69.23 (2016) on the follow-up of the report of the Consultative Expert Working Group on Research and Development: Financing and Coordination, WHA67.20 (2014) on regulatory system strengthening for medical products, WHA67.23 (2014) on health intervention and technology assessment in support of universal health coverage, WHA74.6 (2021) on strengthening local production of medicines and other health technologies to improve access, and WHA74.7 (2021) on strengthening WHO preparedness for and response to health emergencies, which notes the importance of basic and clinical research and recognizes the critical role of international collaboration in research and development, including in multicountry clinical and vaccine trials, as well as rapid diagnostics test and assay development, while acknowledging the need for further rigorous scientific evidence; Noting the recommendations made by the Independent Panel for Pandemic Preparedness and Response in their review “COVID-19: make it the last pandemic”2 relating to health research and development, including clinical trials; 1 “A clinical trial is defined by WHO as any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Clinical trials may also be referred to as interventional trials. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc. This definition includes Phase I to Phase IV trials.” Joint statement on public disclosure of results from clinical trials, 2017 (https://www.who.int/news/item/18-05-2017-joint-statement-on-registration, accessed 25 May 2022). 2 Independent Panel for Pandemic Preparedness and Response. COVID-19: make it the last pandemic, 2021 (https://theindependentpanel.org/wp-content/uploads/2021/05/COVID-19-Make-it-the-Last-Pandemic_final.pdf, accessed 25 May 2022). WHA75.8 2 Recognizing that well-designed1 and well-implemented clinical trials are indispensable for assessing the safety and efficacy of health interventions; Noting the role of clinical trials in the development of safe and efficacious new health interventions, and in informing associated comparative cost–effectiveness evaluations vis-à-vis existing interventions with a view to promoting the affordability of health products; Noting also that clinical trials on new health interventions are likely to produce the clearest result when carried out in diverse settings, including all major population groups the intervention is intended to benefit, with a particular focus on under-represented populations; Recognizing the potential benefits available from collaboration, coordination and the exchange of information between public and non-public funders of clinical trials, while actively preventing and managing conflicts of interest, and noting the potential benefits from public and non-public funders of clinical trials taking steps to ensure funding is targeted towards well-designed and well-implemented clinical trials that will produce actionable evidence regarding health interventions that address public health priorities and in particular the health needs of developing countries, such as neglected tropical diseases, while seeking to strengthen the capability in developing countries to conduct scientifically and ethically sound clinical trials; Recognizing also the essential contribution of clinical trial participants; Underscoring that clinical trials should be health-needs driven, evidence based, well designed and well implemented and be guided by established ethical guidance, including principles of fairness, equity, justice, beneficence and autonomy; and that clinical trials should be considered a shared responsibility; Acknowledging the importance of promoting equity in clinical trial capability, including by enhancing the core competencies of research personnel, ensuring human subject protections from the risks of clinical trials and acknowledging the shared benefits from the results generated from clinical research and development, including clinical trials, both by strengthening the clinical trial global ecosystem to evaluate health interventions and by working to strengthen country capacities to conduct clinical trials that provide the highest protections to human subjects and meet relevant regulations and internationally harmonized standards by considering: (a) systematic assessment of country-level clinical trial capabilities to promote the ability to conduct rigorous clinical trials compliant with international guidelines and the ability to safeguard human subjects; (b) strengthened global clinical trial capabilities, in coordination with existing organizations and structures, in order to promote well-designed and well-implemented clinical trials that produce high-quality evidence, as well as to ensure trials are designed to reflect the heterogeneity of those who will ultimately use or benefit from the intervention being evaluated, and are conducted in diverse settings, including all major population groups the intervention is intended to benefit, with a particular focus on under-represented populations; (c) where possible, inclusion of all trial stakeholders, including representatives of patient groups, according to best practices in the development of clinical trials with affected communities to ensure that the health interventions address their needs, such as solutions on neglected tropical diseases; (d) that clinical trial participants include all major population groups that the intervention is intended to benefit; 1 Throughout this resolution “well-designed trials” refers to trials that are scientifically and ethically appropriate. For submission to medical product regulatory authorities, trials should adhere to International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines and some Member States may consider International Coalition of Medicines Regulatory Authorities guidelines. In order to generate evidence that is robust enough to support decision-making, such as widespread use of therapeutics or preventives, trials should be designed, conducted, analysed and reported appropriately. A well-designed trial must also be practically feasible to conduct. WHA75.8 3 (e) promoting transparent and voluntary sharing, while ensuring information and data security, of both well-designed clinical trial methodologies and the results of clinical trials, including negative results, through open-source methods internationally to enable capability-building in diverse settings; and (f) that regulatory measures and other related processes be solidly defined and implemented, including for public health emergencies of international concern; Recognizing that data from clinical trials play an important role in informing cost–effectiveness assessments of new health interventions and their comparison with existing interventions in order to assess their affordability within the context of national health systems, 1. CALLS ON Member States,1 in accordance with their national and regional legal and regulatory frameworks and contexts and, as appropriate: (1) to prioritize the development and strengthening of national clinical trial capabilities able to comply with international standards of trial design and conduct and human subject protections as well as strengthening and developing national regulatory and quality-control frameworks and authorities; (2) to increase clinical trial capability, and strengthen clinical trials policy frameworks, particularly in developing countries, to enable a greater number of clinical trial sites that can conduct well-designed and well-implemented clinical trials, and to ensure readiness for coordination of trials through existing, new or expanded clinical trial networks that meet relevant regulations and internationally harmonized standards, promoting sharing of information and best practices on efficient and ethical clinical trial design and delivery, and in designing, preparing and conducting clinical trials; (3) to coordinate clinical trials research priorities based on public health needs of Member States including collaborative and, as appropriate, multicountry and multiregional clinical trials when mutually beneficial, while avoiding unnecessary duplication of work, taking into account that aligning clinical trials across countries will require preparatory work, including the coordination, as appropriate, in national regulatory practices and funding frameworks; (4) to collaborate with private-sector funders and academic institutions, while actively preventing and managing conflicts of interest, to encourage the targeting of clinical trials towards the development of health interventions that address public health priorities and concerns of global, regional and national importance, including communicable and noncommunicable diseases, with a focus on the health needs of developing countries, and that evaluate the safety and efficacy of health interventions, including having special regard to common diseases in low- and middle-income countries, unmet medical needs, rare diseases and neglected tropical diseases; (5) to note and, as appropriate, benefit from the potential role of regional organizations in coordinating clinical trials and recruiting participants; (6) to encourage research funding agencies to prioritize and fund clinical trials that are well-designed and well-implemented, conducted in diverse settings and include all major population groups the intervention is intended to benefit, and have adequate statistical power, and relevant control groups and interventions in order to generate the scientifically robust and 1 And, where applicable, regional economic integration organizations. WHA75.8 4 actionable evidence needed to inform public health policy, regulatory decisions and medical practice while preventing underpowered, poorly designed clinical trials and avoiding the exposure of clinical trials participants to unjustified and unnecessary risk, in normal times as well as in public health emergencies of international concern, including through: (a) encouraging investment in well-designed clinical trials, including through clinical trials networks that are developed in collaboration with affected communities, with a view to addressing their public health needs and with the potential for trials to contribute to clinical trial capabilities, including strengthening the core competencies of research personnel, particularly in developing countries; (b) introducing grant conditions for funding clinical trials to encourage the use of standardized data protocols where available and appropriate and to mandate registration in a publicly available clinical trial registry within the WHO International Clinical Trials Registry Platform or any other registry that meets its standards; (c) promoting, as appropriate, measures to facilitate the timely reporting of both positive and negative interpretable clinical trial results in alignment with the joint statement on public disclosure of results from clinical trials1 and the International Coalition of Medicines Regulatory Authorities and WHO joint statement on transparency and data integrity,2 including through registering the results on a publicly available clinical trial registry within the WHO International Clinical Trials Registry Platform and encouraging timely publication of the trial results, preferably in an open-access publication; (d) promoting transparent translation of results, including comparison with existing treatments and data on effectiveness, based on thorough assessment, into clinical guidelines where appropriate; (e) exploring measures during public health emergencies of international concern to encourage researchers to rapidly and responsibly share interpretable results of clinical trials, including negative results, with national regulatory bodies or other appropriate authorities, including WHO, for clinical guideline development and emergency use listing, to support rapid regulatory decision-making and emergency adaptation of clinical and public health guidelines as appropriate, including through pre-print publication; (7) to support ethics committees and regulatory authorities to enable efficient governance processes to focus on the fundamental scientific and ethical principles that underpin randomized controlled trials, maintaining patient and other trial participant protections, including personal data protection and acting proportionately to risk, to best support well-designed and well-implemented clinical trials and facilitate the development of preparedness for clinical trials including, when appropriate, multicountry trials during public health emergencies of international concern, where scientifically appropriate, while embracing flexibility and innovation; 1 Joint statement on public disclosure of results from clinical trials, 2017 (https://www.who.int/news/item/18-05- 2017-joint-statement-on-registration, accessed 25 May 2022). 2 International Coalition of Medicines Regulatory Authorities and WHO joint statement on transparency and data integrity, 2021 (https://www.who.int/news/item/07-05-2021-joint-statement-on-transparency-and-data-integrityinternational- coalition-of-medicines-regulatory-authorities-(icmra)-and-who, accessed 25 May 2022). WHA75.8 5 (8) to support new and existing mechanisms to facilitate rapid regulatory decision-making during public health emergencies of international concern, so that: (a) safe, ethical, well-designed clinical trials can be approved and progress quickly; (b) data from clinical trials can be assessed rapidly, including through WHO Emergency Use Listing procedure, and health interventions deemed safe and effective swiftly authorized; (9) to facilitate – while protecting confidentiality of information when appropriate, in normal times as well as in public health emergencies of international concern – sharing among regulatory authorities of: (a) their assessments of clinical trial protocols to enable the implementation of rigorous protocols in practice; (b) assessment reports on health interventions with potential significance and public health importance to inform, when possible, decision-making processes in other countries, including for potential regulatory assessments and decisions related to the inclusion of health interventions in their national health system, as well as for safety monitoring; (10) to support new and existing mechanisms to facilitate the rapid interpretation of data from clinical trials to develop or amend, as necessary, relevant guidelines during public health emergencies of international concern; (11) to facilitate collaboration and synergies among actors, institutions and networks in the clinical evidence ecosystem throughout the continuum from clinical research to utilization of data from clinical trials in clinical practice through comparative evidence evaluations, evidence synthesis, health technology assessments, regulatory decisions, comparative cost–effectiveness analysis vis-à-vis existing health interventions and, as appropriate, development of evidenced based guidelines and monitoring of implementation in clinical practice; 2. INVITES international nongovernmental organizations and other relevant stakeholders to explore opportunities to coordinate research priorities, and promote investments in clinical trial research and the effective, equitable and timely deployment of resources and funding, while actively preventing and managing conflicts of interest, to support robust, quality clinical trials as well as to strengthen clinical trial research capacities globally, particularly in developing countries and for diseases disproportionately affecting developing countries; 3. REQUESTS the Director-General: (1) to organize, in a transparent manner, stakeholder consultations, in line with the Framework of Engagement with Non-State Actors, with Member States, nongovernmental organizations including patient groups, private-sector entities including international business associations, philanthropic foundations and academic institutions, as appropriate, on the respective roles of the WHO Secretariat, Member States1 and non-State actors, and to identify and propose to Member 1 And, where applicable, regional economic integration organizations. WHA75.8 6 States, for consideration by the governing bodies, best practices and other measures to strengthen the global clinical trial ecosystem, taking into account relevant initiatives where appropriate; (2) to review existing guidance and develop, following the standard WHO processes, new guidance as needed on best practices for clinical trials, including on strengthening the infrastructure needed for clinical trials, to be applied in normal times and with provisions for application during a public health emergency of international concern, taking into account relevant initiatives and guidelines as appropriate, such as those led by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and other organizations by providing, as appropriate: (a) guidance on best practices to help to guide Member States’ implementation of scientifically and ethically sound clinical trials within their national and regional contexts; (b) guidance on best practices for non-State actors in the design and conduct of clinical trials and in strengthening the global clinical trial ecosystem to meet the needs of major population groups that the intervention is intended to benefit, with a particular focus on under-represented populations, developed in consultation with Member States1 and relevant non-State actors; (3) to provide to Member States, on their request, guidance, taking into account relevant initiatives and guidelines, as appropriate, on best practices for developing the legislation, infrastructure and capabilities required for clinical trials, taking into account national and regional contexts; (4) to engage with, as appropriate, relevant non-State actors in line with the Framework of Engagement with Non-State Actors to strengthen clinical trial capabilities, particularly in developing countries, on innovations that meet the needs of major population groups that the intervention is intended to benefit, with a particular focus on under-represented populations; (5) to present a substantive report outlining progress in the activities requested of the Director-General in this resolution for consideration by the Seventy-sixth World Health Assembly in 2023 through the Executive Board at its 152nd session. Seventh plenary meeting, 27 May 2022 A75/VR/7 = = = 1 And, where applicable, regional economic integration organizations. SEVENTY-FIFTH WORLD HEALTH ASSEMBLY A75/22 Provisional agenda item 16.4 19 May 2022 Implementation of the International Health Regulations (2005) Report by the Director-General 1. This document is submitted in response to resolution WHA61.2 (2008), and to decision WHA71(15) (2018) on Implementation of the International Health Regulations (2005): five-year global strategic plan to improve public health preparedness and response, 2018–2023, in which the Health Assembly requests the Director-General “to submit every year a single report to the Health Assembly on progress made in implementation of the International Health Regulations (2005), containing information provided by States Parties and details of the Secretariat’s activities, pursuant to paragraph 1 of Article 54 of the International Health Regulations (2005)”. Pursuant to the request in resolution WHA74.7 (2021) on strengthening WHO preparedness for and response to health emergencies, a report on implementation of the resolution1 is submitted separately. EVENT MANAGEMENT Event-related information 2. Information on events monitored by the Secretariat comes from a variety of sources, including national government agencies, National IHR Focal Points, WHO offices, news media and other organizations or partners. The Secretariat routinely requests verification of information on such events under Article 10 of the Regulations. Delays continued to be observed in 2021 in States Parties’ notification of events to the Secretariat as well as their response to requests for event verification under Articles 6 and 10 of the Regulations. 3. In 2021, events monitored by the Secretariat resulted in 104 publications on the Event Information Site for National IHR Focal Points (EIS), relating to 57 country-specific public health events. Most event updates concerned acute hepatitis E, cholera, influenza due to identified avian or animal influenza viruses, Ebola virus disease, Middle East respiratory syndrome, yellow fever and monkeypox. In parallel, 127 announcements were published on the EIS, mainly relating to additional health measures in response to coronavirus disease (COVID-19) and to variants of concern of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Additional reporting on COVID-19 was undertaken through weekly epidemiological updates, with 53 such updates published in 2021. WHO also published on its website 38 updates on new and ongoing confirmed public health events as disease outbreak news in 2021, related to 21 events in 22 countries. 1 Document A75/10. A75/22 2 Emergency committees 4. The IHR Emergency Committee regarding ongoing events and context involving transmission and international spread of poliovirus is entering its eighth year of existence following the initial determination by the Director-General that the event constituted a public health emergency of international concern in April 2014. In 2021, it continued to meet on a quarterly basis.1 At its thirty-first meeting on 28 February 2022, multiple outbreaks of circulating vaccine-derived poliovirus remained a concern, as well as the continued potential effects of COVID-19 on polio eradication. On the advice of the Committee, the Director-General maintained the status of a public health emergency of international concern and issued revised temporary recommendations. 5. The IHR Emergency Committee for COVID-19 met on four occasions in 2021, in line with decision WHA74(15). At its eleventh and latest meeting on 11 April 2022, the Director-General followed the advice of the Committee and maintained the status of a public health emergency of international concern, issuing updated temporary recommendations under the International Health Regulations (2005).2 Review Committee on the Functioning of the International Health Regulations (2005) during the COVID-19 Response 6. The Review Committee was convened by the Director-General on 8 September 2020 and conducted its work until April 2021, supported throughout by the IHR Secretariat. The Committee’s mandate, based on resolution WHA73.1 (2020) and in accordance with Article 50 of the International Health Regulations (2005), was to review the functioning of the Regulations during the COVID-19 response, with reference to the provisions of the Regulations as appropriate. In this regard, the Review Committee undertook an article-by-article assessment of the functioning of the Regulations to examine whether the perceived shortcomings in their effectiveness during the COVID-19 response were due to the design of the Regulations or from challenges in their implementation. Overall, the Review Committee noted that the design of the Regulations fulfils its original aim as the agreed framework for global health protection, and no major amendments are needed at this stage. However, the interpretation and implementation of the Regulations by both the WHO Secretariat and States Parties is suboptimal. 7. The Review Committee’s report,3 which includes 40 recommendations in ten areas to strengthen implementation of and compliance with the International Health Regulations (2005), was presented by the Director-General to the Seventy-fourth World Health Assembly in May 2021. As decided by the Health Assembly in resolution WHA74.7, the findings and recommendations of the Review Committee are to be considered by the newly established Member States Working Group on Strengthening WHO Preparedness and Response to Health Emergencies, together with those of the Independent Panel for Pandemic Preparedness and Response and of the Independent Oversight and Advisory Committee for the WHO Health Emergencies Programme. Pursuant to the same resolution, the Working Group will submit a report with proposed actions for the WHO Secretariat, Member States and non-State actors, as 1 See https://www.who.int/news/item/11-03-2022-statement-of-the-thirty-first-polio-ihr-emergency-committee (accessed 30 March 2022). 2 See https://www.who.int/news/item/13-04-2022-statement-on-the-eleventh-meeting-of-the-international-health- regulations-(2005)-emergency-committee-regarding-the-coronavirus-disease-(covid-19)-pandemic (accessed 19April 2022). 3 Document A74/9 Add.1. A75/22 3 appropriate, for consideration by the Seventy-fifth World Health Assembly through the Executive Board at its 150th session. 8. In addition, in accordance with Article 55 of the International Health Regulations (2005), one State Party submitted proposed amendments to the Regulations, which were communicated by the Director-General to all States Parties on 20 January 2022 for consideration by the Seventy-fifth World Health Assembly.1 In accordance with decision EB150(3), the Member States Working Group on Strengthening WHO Preparedness and Response to Health Emergencies will include, as part of its ongoing work, dedicated time to allow for discussions on strengthening of the International Health Regulations (2005), including through implementation, compliance and potential amendments. STRENGTHENING NATIONAL CORE CAPACITIES 9. In 2021, the Secretariat developed and published the second edition of the State Party Self-Assessment Annual Reporting tool, taking into account the lessons learned from the COVID-19 pandemic, and continued to provide the tool in an electronic format that allows States Parties to report online, thereby facilitating the reporting by States Parties, as well as providing transparency, enabling real-time monitoring of reports submitted and offering opportunities for quality checks of data provided. Up-to-date data for the 2021 cycle are available on WHO’s electronic State Parties Self-Assessment Annual Reporting portal.2 10. The Secretariat continued to work with States Parties to strengthen their laboratory core capacities, by leveraging short-term preparedness, readiness and response activities for COVID-19 in order to improve longer-term laboratory capacities for other epidemic-prone diseases and high threat pathogens. Technical assistance has been provided to national public health laboratory networks through both online and on-site workshops, training and mentoring visits. The investments made in sequencing platforms for SARS-CoV-2 should benefit other pathogens of epidemic and pandemic potential. Laboratory workforces have been strengthened through the increased implementation of the Global Laboratory Leadership Programme,3 a unique learning and mentoring programme for laboratory managers and leaders aimed at strengthening laboratory systems through a One Health approach. 11. The Secretariat continued to provide technical support for enhancing core risk communication capacities by leveraging and coordinating the efforts of key international and national agencies and partners, spanning the public health and humanitarian sectors. The Collective Service for Risk Communication and Community Engagement is a coordination mechanism involving WHO, UNICEF, the International Federation of Red Cross and Red Crescent Societies and the Global Outbreak Alert and Response Network.4 The Collective Service, which was established during the COVID-19 pandemic, created a comprehensive data repository and global dashboard on social behavioural information in relation to COVID-19 drawing from over 200 social and behavioural surveys. The Collective Service also developed interim guidance, COVID-19 materials and products and two online training courses (“risk communication and community engagement challenges” and “social and behavioural insights COVID-19 data collection tool for Africa”), available on the OpenWHO platform. 1 See document A75/1 Add.1. 2 See e-SPAR platform (https://extranet.who.int/e-spar/, accessed 30 March 2022). 3 See https://www.who.int/initiatives/global-laboratory-leadership-programme (accessed 9 February 2022). 4 See https://www.rcce-collective.net/the-collective-service/ (accessed 9 February 2022). A75/22 4 COMPLIANCE WITH REQUIREMENTS OF THE REGULATIONS 12. This section provides information about compliance with several requirements of the Regulations, including those in the areas of additional health measures; event notification and verification; the establishment and maintenance of National IHR Focal Points; and key provisions in relation to points of entry and yellow fever vaccination. Additional health measures 13. The Secretariat has continued to implement a structured approach in coordination with the regional offices for monitoring States Parties’ compliance regarding additional health measures. In accordance with Article 43 of the Regulations, the Secretariat shared information about these measures, and, when available, the public health rationale, with all States Parties on a weekly basis, through 48 updates published on the secure platform of the Event Information Site for National IHR Focal Points. The Secretariat’s analysis of these measures has regularly informed the deliberations of the IHR Emergency Committee for COVID-19. 14. As at 28 January 2022, the Secretariat has received reports of more than 9000 new measures that significantly interfere with international travel or trade, comprising extensions, revisions or terminations of such measures. The measures include air, land and maritime border closures for one or more countries, quarantine requirements, testing before, during or after arrival and, more recently, requirement of proof of vaccination against COVID-19 as a condition for travel. 15. As of 28 January 2022, 38 countries introduced requirements of proof of vaccination against COVID-19 as the only condition for travel, at least for specific population groups (such as non-nationals and non-immunized or non-essential travellers) or types of travel (for example, travel to or from red-zone countries), against the temporary recommendations issued by the Director-General on the advice of the Emergency Committee since its sixth meeting in January 2021,1 and extended at all subsequent meetings, including at the latest meeting in January 2022.2 16. The rationale provided by States Parties who reported the measures to WHO during 2021 include uncertainties about the epidemiology of new variants of concern and their transmissibility (Delta in early 2021 and Omicron in late 2021), their impact on the clinical profile of the disease, limited or unknown effectiveness of treatments and vaccines, as well as the vulnerabilities of public health response systems in case of importation of the disease. 17. Following WHO’s designation on 26 November 2021 of the SARS-CoV-2 variant B.1.1.529 as a variant of concern, named Omicron, WHO issued updated travel advice, stating that “[b]lanket travel bans will not prevent the international spread, and they place a heavy burden on lives and livelihoods. In addition, they can adversely impact global health efforts during a pandemic by disincentivizing countries to report and share epidemiological and sequencing data.”3 Despite this, 56 countries 1 See https://www.who.int/news/item/15-01-2021-statement-on-the-sixth-meeting-of-the-international-health- regulations-(2005)-emergency-committee-regarding-the-coronavirus-disease-(covid-19)-pandemic (accessed 30 March 2022). 2 See https://www.who.int/news/item/19-01-2022-statement-on-the-tenth-meeting-of-the-international-health- regulations-(2005)-emergency-committee-regarding-the-coronavirus-disease-(covid-19)-pandemic (accessed on 7 February 2022). 3 See https://www.who.int/news-room/articles-detail/who-advice-for-international-traffic-in-relation-to-the-sars-cov- 2-omicron-variant (accessed 7 January 2022). A75/22 5 introduced temporary travel restrictions concerning South Africa, where the variant was first reported, and other countries, primarily affecting between six and eight countries in southern Africa. By 10 December 2021, 112 State Parties had reported such measures, including denial of entry, flight suspension and additional testing and/or quarantine for travellers arriving from those countries. As at 10 February 2022, 36 countries still applied a travel or flight restriction due to the variant of concern, mainly involving southern African countries. Event notification and verification and National IHR Focal Points 18. Several WHO regional offices have continued the monitoring and reporting of States Parties’ compliance with obligations under the Regulations with regard to event notification and verification. 19. The Secretariat has continued to facilitate the round-the-clock accessibility of all National IHR Focal Points and WHO’s IHR Contact Points. In 2021, 66% of National IHR Focal Points confirmed or updated their contact information. By the end of 2021, there were 992 country-designated users of the Event Information Site for National IHR Focal Points, of whom 143 were new users and 443 were updated accounts. Responding to requests by the Secretariat concerning the contact details of the Focal Points and users of the Site remains a challenge in a number of States Parties. 20. The Secretariat continued to support the learning of National IHR Focal Points and others involved in implementation of the Regulations, notably by boosting access to the Health Security Learning Platform and related online courses. In 2021, several new initiatives were launched to this end, including an National IHR Focal Points onboarding learning package, a training course on the Event Information Site and a training course on the IHR monitoring and evaluation framework, all of which are available on the learning platform. The Global and Regional Knowledge Networks for National IHR Focal Points and national rapid response teams continued to facilitate the sharing of experiences and peer-to-peer learning among their respective members. 21. Two IHR introduction workshops were organized remotely for the National IHR Focal Points in two European countries in 2021. A training course on the Epidemic Intelligence from Open Sources initiative was organized for public health intelligence teams in two European countries (one was held in person and the other remotely). Relevant technical guidance on COVID-19 issues has been shared with Focal Points in Europe in a timely manner through the COVID-19 Surveillance Pillar. Points of entry 22. Since 2007, 112 of a total of 152 coastal States Parties and four landlocked States Parties with inland ports have sent WHO the list of ports authorized to issue ship sanitation certificates, as required by the Regulations. The global list of authorized ports is now 1872.1 23. The Secretariat continued efforts to foster collaboration with its partners to promote the implementation of the Regulations at points of entry for international travel and transport, during routine periods and health emergencies. The Secretariat supported the International Maritime Organization in its process of reviewing and updating the Annex of the Convention on Facilitation of International Maritime Traffic, in an effort to ensure its alignment with relevant provisions of the Regulations. In the context of the COVID-19 pandemic, as well as other health emergencies such as the Ebola virus disease outbreak in the Democratic Republic of the Congo, extensive and regular coordination has been 1 See the list of ports authorized to issue ship sanitation certificates (https://extranet.who.int/ihr/poedata/data_entry/ctrl/portListPDFCtrl.php, accessed on 9 February 2022). A75/22 6 maintained with global partner organizations in the areas of travel, transport, economic development, migration and tourism, with the aim of sharing scientific knowledge and public health surveillance data, and promoting a coordinated multisectoral response to health emergencies, including with regard to the protection of essential transport workers. Key partners included, among others, ICAO, ILO, IMO, IOM, OECD and the World Tourism Organization. 24. In collaboration with partners, the Secretariat has produced and updated policy and technical guidance and operational tools, and organized global and regional webinars, consultations and training to support countries in implementing a risk-based approach to international traffic during health emergencies, and strengthening public health measures and capacities under the Regulations at points of entry, including in the context of the COVID-19 pandemic. 25. The Secretariat continued to conduct regular systematic reviews to gather the evidence available on the effectiveness of travel-related measures to minimize the exportation, importation and onwards transmission of SARS-CoV-2, as well as their broader impact on international travellers. 26. In July 2021, the Secretariat updated its interim guidance documents on considerations to implement a risk-based approach to international travel in the context of COVID-19, incorporating the emergence of new variants in the risk assessment and factoring COVID-19 vaccination into the overall risk management process. Other updated sectoral guidance documents include the implementation guide for the management of COVID-19 on board cargo ships and fishing vessels. 27. Regional offices have supported countries in strengthening capacities and implementing public health measures at points of entry in the context of COVID-19 and beyond. The WHO Regional Office for Europe has supported online consultations with Member States and organized assessments of and training on points of entries for several countries. It also published an operational framework for international travel-related public health measures in the context of COVID-19 to improve coordinated national decision-making regarding additional health measures that significantly interfere with international traffic under Article 43 of the International Health Regulations (2005). The WHO Regional Office for Europe has published three public health checklists for controlling the spread of COVID-19 at ground crossings, in aviation and in ships, sea ports and inland ports. Yellow fever vaccination 28. Information about States Parties’ requirements for vaccination against yellow fever is collected annually through a questionnaire sent by the Secretariat to all National IHR Focal Points. The information is published in Annex 1 of WHO’s report on international travel and health.1 In addition, the WHO Secretariat also each year publishes State Parties’ requirements and WHO’s recommendations on vaccination and prophylaxis for international travellers, particularly for yellow fever, malaria and poliomyelitis.2 Currently, 120 States Parties and territories request a certificate of vaccination against yellow fever for incoming travellers. In 2020, 122 countries confirmed that international certificates of vaccination against yellow fever, using WHO-approved vaccines, are now accepted as valid for the life of the person vaccinated, which they should be in accordance with Annex 7 of the Regulations, as 1 Annex 1, Countries with risk of yellow fever transmission and countries requiring yellow fever vaccination (May 2021) (https://www.who.int/publications/m/item/countries-with-risk-of-yellow-fever-transmission-and-countries- requiring-yellow-fever-vaccination-(may-2021), accessed 8 February 2022). 2 Vaccination requirements and recommendations for international travellers; and malaria situation per country – 2021 edition (https://www.who.int/publications/m/item/vaccination-requirements-and-recommendations-for-international- travellers-and-malaria-situation-per-country-2021-edition, accessed 8 February 2022). A75/22 7 amended by resolution WHA67.13 (2014) on implementation of the Regulations. The survey for 2022 is ongoing and results will be published in the latter part of 2022. ACTIVITIES BY THE SECRETARIAT IN SUPPORT OF STATES PARTIES TO IMPLEMENT THE REGULATIONS 29. The Secretariat has continued to provide sustained support to States Parties to enhance preparedness for all hazards. 30. In 2021, the Secretariat continued to provide the State Party Self-Assessment Annual Reporting tool in an electronic format that allows States Parties to report online, thereby facilitating the reporting by States Parties, as well as providing transparency, enabling the real-time monitoring of reports submitted and offering opportunities for quality checks of data provided. In March 2021, the Secretariat hosted a global consultation followed by a series of technical working group meetings to review the State Party Self-Assessment Annual Reporting and joint external evaluation tools and processes in order to incorporate lessons learned from the COVID-19 pandemic in ways that make these national preparedness assessments more reflective of the performance of country capacities to detect and respond to severe epidemic and pandemic threats. This will also facilitate and strengthen the development, review and implementation of national action plans for health security. 31. As at 14 January 2022, 110 COVID-19 intra-action reviews had been carried out by 71 countries, 114 joint external evaluations had been completed, 170 simulation exercises undertaken and 68 after- action reviews conducted. The Secretariat also developed intra-action review and simulation exercise packages1 on vaccination to support countries in strengthening their functional capacities in order to address critical gaps during the COVID-19 pandemic.2 The intra-action review package is available in all of WHO’s six official languages as well as in Portuguese. In June 2021, the Secretariat supported an after-action review of the response to the ninth, tenth, eleventh and twelfth outbreaks of Ebola virus disease in the Democratic Republic of the Congo. 32. In 2021, the Secretariat published the WHO Strategic Toolkit for Assessing Risks (STAR),3 which is a comprehensive toolkit to support countries in identifying all-hazard preparedness and disaster risks. The Toolkit also facilitates the development of robust policies, strategies and plans to address the vulnerabilities that countries can face in terms of health emergencies and disasters. 33. In 2021, the Secretariat developed technical and procedural guidance for Member States to undertake voluntary pilots of the Universal Health and Preparedness Review, which has been proposed as a means of increasing accountability, solidarity and transparency among countries in health emergency preparedness gap identification and capacity-building. The Universal Health and Preparedness Review is a voluntary peer-to-peer review mechanism, led and owned by Member States, to promote greater, more effective international cooperation and global solidarity by bringing countries and stakeholders together to enhance preparedness. In September 2021, WHO established a technical advisory group, comprising 21 international experts, to advise on the conceptual development of the mechanism. In accordance with resolution WHA74.7, a detailed concept note on the proposed Universal Health and Preparedness Review mechanism has been developed and submitted for consideration by the 1 See https://www.who.int/emergencies/diseases/novel-coronavirus-2019/training/simulation-exercise (accessed 9 February 2022). 2 See the COVID-19 Strategic Preparedness and Response Plan (https://www.who.int/publications/i/item/WHO- WHE-2021.02, accessed 4 January 2022). 3 See https://www.who.int/publications/i/item/9789240036086 (accessed 9 February 2022). A75/22 8 Seventy-fifth World Health Assembly following a consultation process with all Member States in April 2022.1 Four country pilot tests were conducted between December 2021 and May 2022 in Central African Republic, Iraq, Portugal and Thailand and were facilitated by a WHO support mission. As at 4 May 2021, 21 Member States have expressed interest in piloting the Universal Health and Preparedness Review 34. To further support States Parties in the strengthening of their One Health capacities, the Secretariat, jointly with the World Organisation for Animal Health and the Food and Agriculture Organization of the United Nations, continued to support States Parties to strengthen multisectoral collaboration at the human-animal-environment interface. National bridging workshops were organized to facilitate countries’ reviews of their gaps in coordination for zoonotic events and to develop operational road maps to improve multisectoral capacities. The workshops were organized in four additional countries in 2021, with the total number of workshops completed across all countries standing at 36 as at 14 January 2022. To support the implementation of activities in the national bridging workshop road maps, 10 WHO country offices have recruited national bridging workshop catalysts (national One Health experts). In addition, in 2021 multiple countries received support on using the principles and best practices set out in the Tripartite Zoonoses Guide.2 This included launching online training, publishing the Joint Risk Assessment Operational Tool and piloting the Multisectoral Coordination Mechanism Operational Tool and the Surveillance and Information Sharing Operational Tool. 35. The Secretariat has also made progress in developing a dynamic preparedness metric framework to address the need for more dynamic measures to reflect current and changing risks and countries’ corresponding preparedness status, including hazards and threats, vulnerabilities and capacities. The framework will bring together current preparedness assessment tools and metrics with other relevant interdependencies in order to more effectively identify national strengths and gaps and prioritize capacity-building actions, including those relating to the WHO benchmarks for capacities under the International Health Regulations (2005).3 36. The Secretariat has undertaken a review of the cost estimates for improving health emergency preparedness at the national and global levels. This work will inform and facilitate the development of investment cases to better – and more sustainably – finance preparedness and capacity-building. 37. The Secretariat has launched a series of small research grants to document, synthesize and disseminate knowledge on existing national best practices for implementation of the Regulations. So far, the Secretariat has facilitated 13 grants across nine countries in the Eastern Mediterranean Region, with further support across more regions planned for the near future.4 38. In 2021, the Secretariat published “Health Systems for Health Security”,5 a framework to support countries and partners in bringing together the capacities required for implementation of the Regulations, as well as the components of health systems and other sectors needed to ensure effective multisectoral 1 Document A75/21. 2 See https://www.who.int/initiatives/tripartite-zoonosis-guide (accessed 9 February 2022). 3 See https://www.who.int/publications/i/item/9789241515429 (accessed 9 February 2022). 4 See Supporting research on health security preparedness in the Eastern Mediterranean Region (https://tdr.who.int/newsroom/news/item/03-11-2021-supporting-research-on-health-security-preparedness-in-the-eastern- mediterranean-region, accessed 7 February 2022). 5 See https://www.who.int/publications/i/item/9789240029682 (accessed 9 February). A75/22 9 and multidisciplinary preparedness for and management of health emergencies. The framework is an innovative approach that complements existing concepts and tools for global health security capacity-building and that facilitates more synergistic working relationships between stakeholders in health security, health systems and other sectors to ensure multisectoral and multidisciplinary health emergency preparedness. It also contains a list of 22 thematic areas for consideration in building country capacities towards health security. 39. The Secretariat continued to support States Parties in applying the WHO benchmarks for capacities under the International Health Regulations (2005) in order to support emergency preparedness capacity-building. The benchmarks and corresponding actions can strengthen countries’ emergency preparedness through the development and implementation of national action plans for health security. The Secretariat has also developed a benchmarks reference library to provide States Parties, partners and public health stakeholders with direct access to relevant guidance, tools and materials that support the implementation of proposed capacity-building actions in relation to the benchmarks. 40. The Secretariat, in 2021, advanced progress towards establishing and piloting the Global Strategic Preparedness Network in line with resolution WHA73.8 (2020) on strengthening preparedness for health emergencies: implementation of the International Health Regulations (2005), including through extensive strategic and technical consultations with Member States, international organizations, multisectoral networks and partners. The network will facilitate implementation of national health security plans and capacity-building through a network of technical experts that can work with countries in addressing identified preparedness gaps. 41. In 2021, the Secretariat revamped and enhanced WHO’s portal for the Strategic Partnership for IHR and Health Security. The portal now has expanded functionalities that can be used to scale up multisector coordination and collaboration for preparedness and to better track and monitor national preparedness investments in relevant capacity-building activities, including those contained in national action plans for health security. 42. The Secretariat also further expanded the implementation of the WHO Resource Mapping (REMAP) tool and process to support countries in identifying all nationally available technical and financial resources that can be used to strengthen preparedness. Through REMAP, over 3450 different activities representing a total of over US$ 7.89 billion in disclosed contributions from 62 donors and partners have been tracked and displayed on WHO’s portal for the Strategic Partnership for IHR and Health Security. The portal’s partner matching capabilities have also enabled donors, partners and countries to mobilize multisectoral resources to support emergency preparedness strengthening at the national level. 43. In 2021, the Secretariat developed an e-learning version of the training course on the IHR monitoring and evaluation framework. The course comprises four modules to support public health stakeholders in enhancing their capacity to implement monitoring and evaluation activities, carry out capacity-building planning through national action plans for health security and strengthen national capacities to prevent, detect and respond to health emergency threats like COVID-19. 44. The Secretariat continued to support the development of preparedness case studies to document all best practices, challenges and opportunities for enhancing national health emergency management capacities. In 2021, 12 articles from WHO regional offices were published in a supplement edition of the Weekly Epidemiological Record, six country case studies were published on WHO’s portal for the Strategic Partnership for IHR and Health Security and three interviews with IHR champions were conducted to share knowledge about best practices related to strengthening preparedness against Ebola A75/22 10 virus disease in Guinea, the implementation of strategic risk assessments in the European Region and the application of information and computing technology for preparedness in Rwanda. 45. In the context of country readiness strengthening, WHO continued to support the capacity-building of national rapid response teams. The Secretariat assessed the impact of the national rapid response team training delivered between 2015 to 2020 and the mechanisms contributing to these impacts at the individual, team and organizational levels. The COVID-19 National Rapid Response Teams Online Learning Programme was updated and now comprises eight separate modules offered in English, French and Spanish. 46. Strengthening health emergency preparedness and response is one of the most important health priorities in the South East Asia Region. Throughout the response to COVID-19, Member States, the Secretariat and other partners have worked together through various platforms, including Regional Committee meetings, to identify priority actions to further strengthen health emergency preparedness and response capacities while building national health security systems that are linked to resilient health systems. In the context of COVID-19, the region also regularly communicates with Member States; four virtual meetings have been held with National IHR Focal Points and the Regional Knowledge Network for National IHR Focal Points, to facilitate the exchange of information, experiences and lessons learned. CONCLUSION 47. The implementation of the International Health Regulations (2005) continued to be a challenge in 2021 due to the COVID-19 pandemic. It is expected that the discussions surrounding the potential adoption of a WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response and proposed amendments to the Regulations will contribute in a meaningful way to strengthen the current global architecture and governance for efficient and effective health protection and security. ACTION BY THE HEALTH ASSEMBLY 48. The Health Assembly is invited to note this report. = = = EXECUTIVE BOARD EB150/19 150th session 8 December 2021 Provisional agenda item 15.4 Influenza preparedness Report by the Director-General Background 1. In August 2020, the Seventy-third World Health Assembly adopted decision WHA73(14) on influenza preparedness. The decision included a request to the Director-General to report on implementation of the decision to the Seventy-fifth World Health Assembly through the Executive Board at its 150th session. 2. This report describes progress in strengthening influenza preparedness, notably in implementing the actions requested in decision WHA73(14), and areas where the capacities and systems developed for influenza preparedness have supported the coronavirus disease (COVID-19) pandemic response. Engagement with Member States and stakeholders 3. The Secretariat used different opportunities to reach out to Member States and relevant stakeholders and to provide them with updates on progress in implementing decision WHA73(14). Examples include developing a pre-recorded briefing on key achievements and challenges in implementing the decision, which was distributed to Member States and relevant stakeholders in July 2021, and distributing a questionnaire to seek feedback on WHO’s implementation of the decision, including specific operative paragraphs. Operative paragraph (1): Global Influenza Strategy 2019–2030 4. In decision WHA73(14), the Health Assembly noted the release of the Global Influenza Strategy 2019–2030. The Secretariat is developing the first biennial report on its implementation, which will provide details on activities undertaken to date towards achieving the Strategy’s two high-level outcomes: better global tools and stronger country capacities. The report is expected to be published by the end of 2021 and will be available online. Operative paragraph (2)(a): National influenza pandemic preparedness plans and vaccination programmes 5. Through its guidance on pandemic influenza risk management published in 2017,1 WHO encourages countries to develop, test and update national influenza pandemic preparedness plans to 1 Pandemic influenza risk management: a WHO guide to inform and harmonize national and international pandemic preparedness and response. Geneva: World Health Organization; 2021 (https://apps.who.int/iris/handle/10665/259893, accessed 20 October 2021). EB150/19 2 reflect a risk-based approach so that national plans are flexible, account for national risk assessments, and take into consideration global risk assessments conducted by WHO. 6. The Secretariat previously developed a package of tools for use by countries in developing and updating their national influenza pandemic preparedness plans and in conducting simulation exercises.1 The Secretariat has begun a process to review its pandemic influenza risk management guidance in order to identify areas that can be strengthened based on lessons learned from the COVID-19 pandemic response. 7. In 2013, the Pandemic Influenza Preparedness (PIP) Framework Advisory Group identified five areas of work for focused investments by WHO with the Partnership Contribution preparedness funds. A sixth area on planning for pandemic influenza was added in 2018. Through the sixth area of work, and in alignment with the guidance on pandemic influenza risk management, the Secretariat provides support to countries to develop, test and update their national influenza pandemic preparedness plans. As of June 2021, of the 63 countries that received PIP Partnership Contribution Preparedness funds for pandemic influenza preparedness planning in the 2020–2021 biennium, 35 countries had a plan based on pandemic influenza risk management. Additionally, all 40 countries that received 2018–2019 PIP Partnership Contribution preparedness funds for pandemic influenza preparedness planning were able to develop a COVID-19 response plan in 2020, and 36 of them developed their plans based on their national influenza pandemic preparedness plan within four months after the declaration of the public health emergency of international concern. 8. Safe and efficacious seasonal influenza vaccines are critical to influenza prevention and control efforts, and WHO recommends annual seasonal influenza vaccination as the best intervention for preventing disease and reducing disease severity and societal burden due to influenza. In 2012, WHO released its seasonal influenza vaccination position paper, which recommended the vaccination of priority target groups, including pregnant women, children aged 6–59 months, older adults, individuals with specific chronic medical conditions, and health workers.2 9. The Secretariat has developed an influenza vaccination toolbox, which includes relevant tools and guidance related to influenza vaccine programme development and strengthening for use by Ministry of Health officials, vaccinators, health workers, researchers and other stakeholders.3 10. In addition, the Secretariat is providing support to countries to develop or expand their seasonal influenza vaccination policies and programmes by addressing influenza vaccine hesitancy through understanding and assessing influenza vaccine acceptance, demand and uptake. Operative paragraph (2)(b): Seasonal influenza vaccines, diagnostics and treatments 11. Seasonal influenza prevention and control is possible due to a comprehensive package of interventions, including public health and social measures (such as hand hygiene, physical distancing and respiratory hygiene/etiquette), vaccines, diagnostics and treatments. 1 The relevant resources are available at https://www.who.int/teams/global-influenza-programme/public-health- preparedness (accessed 20 October 2021). 2 The position paper is available at https://apps.who.int/iris/bitstream/handle/10665/241993/WER8747_461- 476.PDF?sequence=1&isAllowed=y (accessed 20 October 2021). 3 The toolbox is available at https://www.who.int/teams/global-influenza-programme/vaccines/influenza-vaccination- toolbox (accessed 20 October 2021). EB150/19 3 12. The Global Influenza Strategy 2019–2030 encourages all countries to establish seasonal influenza prevention and control programmes to protect the vulnerable and contribute to universal health coverage by ensuring access to all available tools. Additionally, the Secretariat has provided support to countries to ensure optimal management of influenza during the COVID-19 pandemic, including by providing recommendations for maintaining influenza surveillance, prevention and control, clinical management, protection of specific populations, and risk communications and community engagement.1 13. Since early 2020, global influenza transmission has been at historic lows, likely due to the preventive measures put in place for COVID-19. The Secretariat has engaged in a series of projects to review and synthesize the available evidence of the impact of public health and social measures on COVID-19. The outcomes will guide and strengthen the collective approach to public health and social measures as a part of epidemic and pandemic preparedness, including for influenza. 14. Safe and efficacious influenza antivirals are available to support the clinical management of patients with or at risk for severe influenza. The Secretariat is updating its guidelines for the clinical management of severe influenza illness to guide clinicians in the care of patients with, or at risk of, severe influenza illness, including those caused by seasonal, zoonotic and pandemic influenza viruses. The guidelines will provide recommendations for treatment with antivirals and adjunctive therapies and the use of diagnostic testing strategies to guide clinical management. 15. Work is being undertaken under the PIP Framework to negotiate voluntary supply agreements with different antiviral manufacturers. In so doing, WHO is putting in place options for access to antivirals that may prove useful against the next influenza virus with pandemic potential. Operative paragraph (2)(c): Pandemic Influenza Preparedness Framework 16. Between January 2012 and September 2021, US$ 241 million have been collected under the PIP Partnership Contribution. Of that, US$ 134 million have been allocated to preparedness and over US$ 102 million have been implemented to date. Approximately US$ 61 million is available in the Pandemic Response Fund, which will be available immediately upon the declaration of the next influenza pandemic. 17. WHO has concluded 14 Standard Material Transfer Agreements 2 with vaccine manufacturers. All commitments under the Agreements are made as a percentage of real-time production. In terms of quantities, the Standard Material Transfer Agreements 2 provide guaranteed access by WHO to a little more than 10% of future pandemic influenza vaccine production, most of which will be donated to WHO. 18. Through the Partnership Contribution preparedness fund, WHO is supporting countries to improve capacities to detect, understand and respond to the emergence of a new influenza virus that could cause a pandemic. Projects have been implemented in 83 countries to address one or more of these objectives, including for example strengthening surveillance, conducting disease burden studies and ensuring efficient regulatory systems for vaccine emergency authorization. 1 The readiness for influenza during the COVID-19 pandemic policy brief is available at https://www.who.int/publications/i/item/WHO-2019-nCoV-Influenza-readiness-COVID-19-2020.1 (accessed 20 October 2021). EB150/19 4 19. Influenza capacities strengthened since 2014 have had a significant impact in the COVID-19 response. As reported every six months in the PIP Framework progress reports,1 highlights include the following: (a) 66 countries integrated COVID-19 into their sentinel surveillance systems for influenza and use an established influenza platform to report and share COVID-19 data; (b) 45 of 48 PIP target countries for the regulatory area of work, which were selected based on their gaps during the 2009 pandemic, were able to authorize COVID-19 vaccines within the first 15 days after WHO issued emergency use listing; (c) the OpenWHO platform that was created and supported under the PIP Framework through 2018 is now institutionalized and has been used extensively for COVID-19 knowledge transfer, with over 5 million enrolments across 33 different courses. Operative paragraph (2)(d): Global Influenza Surveillance and Response System 20. As of 2020, the Global Influenza Surveillance and Response System had grown to over 150 institutions in 125 countries. This includes 147 National Influenza Centres in 123 countries, seven WHO Collaborating Centres, four WHO Essential Regulatory Laboratories, and 13 WHO H5 Reference Laboratories. 21. When the virus responsible for COVID-19, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), emerged in 2019, the Global Influenza Surveillance and Response System was rapidly leveraged to respond and has continued to support the global response to the COVID-19 pandemic. 22. The Global Influenza Surveillance and Response System has provided significant virus detection and sequencing capacities to the COVID-19 pandemic response. As at June 2021: (a) Over 90% of National Influenza Centres were testing for COVID-19; and (b) 92 Global Influenza Surveillance and Response System laboratories from 75 countries had submitted whole genome sequences of SARS-CoV-2 to GISAID, thereby vastly expanding the geographic representation of SARS-CoV-2 genomic sequences. 23. In line with the recommendations of the International Health Regulations (2005) Emergency Committee for COVID-19, the Secretariat encourages countries to leverage influenza capacities for COVID-19 and to support an integrated, end-to-end approach to sentinel surveillance of influenza and SARS-CoV-2 that encompasses sampling all the way to genetic sequencing and sequence data sharing. 24. Further to this integrated approach, the Secretariat is exploring opportunities for systematically enhancing the Global Influenza Surveillance and Response System to serve as an integrated system for surveillance and monitoring of respiratory viruses with epidemic and pandemic potential. This vision for an expanded Global Influenza Surveillance and Response System, referred to as “GISRS+”, builds upon the success of leveraging the System for the COVID-19 pandemic response as well as the previous integration of respiratory syncytial virus surveillance and monitoring into it in 2015. The Secretariat has engaged with Member States, Global Influenza Surveillance and Response System members and 1 PIP Framework progress reports are available at https://www.who.int/initiatives/pandemic-influenza-preparedness- framework/partnership-contribution (accessed 20 October 2021). EB150/19 5 stakeholders to solicit initial feedback on the strengths, challenges, opportunities and priorities for GISRS+. 25. The Secretariat continues to encourage the rapid, systematic and timely sharing of seasonal influenza viruses and influenza viruses with pandemic potential. Instances where national regulations, legislation or other administrative measures have had an impact on virus sharing within the Global Influenza Surveillance and Response System have previously been described.1 26. Additional instances have emerged where national access and benefit-sharing requirements have affected the sharing of seasonal influenza virus, including among countries that are parties to the Nagoya Protocol to the Convention on Biological Diversity.2 Uncertainties have arisen as to whether the terms of reference of Global Influenza Surveillance and Response System institutions fully address the use of seasonal influenza viruses for the development of candidate vaccine viruses, which are precursors for seasonal influenza vaccine production. 27. The Secretariat is engaging with Member States, Global Influenza Surveillance and Response System members and the secretariat of the Convention on Biological Diversity to identify solutions and seek greater clarity on the sharing and use of seasonal influenza viruses. Operative paragraph (2)(e): Synergies among influenza preparedness and response, International Health Regulations (2005) and immunization programmes 28. Through the Global Influenza Strategy, WHO promotes synergies among influenza preparedness and response capacity-building, International Health Regulations (2005) and immunization programmes. 29. The Secretariat has developed a pandemic influenza vaccine response operational plan, which expands upon the pandemic influenza risk management guidance and clarifies the roles, responsibilities, processes and triggers for vaccine response at the beginning of an influenza pandemic. The plan identifies WHO’s declaration of an influenza pandemic as a critical trigger for the vaccine response, including triggering the PIP Framework benefit-sharing mechanisms. At this time, the process associated with, and the requirements for, an influenza pandemic declaration by WHO need greater clarity. The Secretariat intends to build upon existing work, including the pandemic influenza vaccine response operational plan, to identify and advance opportunities for clarifying the processes and requirements for declaring an influenza pandemic. This work will be done in collaboration with the Global Influenza Surveillance and Response System, seeking advice from the PIP Advisory Group and other experts, and will provide the Director-General with options for strengthening the policy basis for declaring an influenza pandemic. 1 Document EB146/18. 2 Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity: text and annex. Available at https://www.cbd.int/abs/doc/protocol/nagoya-protocol-en.pdf (accessed 1 November 2021). EB150/19 6 Operative paragraph (2)(f): Global influenza vaccine production capacity, supply chains and distribution networks 30. The Secretariat regularly monitors global influenza vaccine production capacity, and in 2021, published updated figures based on a 2019 survey.1 31. To address the Assembly’s request in paragraph (2)(f) of decision WHA73(14), the Secretariat sought feedback from Member States and other stakeholders, through an online questionnaire, on gaps in and priorities for influenza vaccine production capacity, supply chains and distribution networks. 32. The Secretariat will continue to consult with Member States and relevant stakeholders on this issue and identify a path forward, which will support the Global Influenza Strategy’s high-level outcome on better global tools. ACTION BY THE EXECUTIVE BOARD 33. The Executive Board is invited to note this report. In its discussions, the Board may wish to focus on: • suggestions for expanding the Global Influenza Surveillance and Response System to include other respiratory viruses with epidemic and pandemic potential; and • guidance for further sensitizing Member States to the importance of timely influenza virus sharing and use. = = = 1 Sparrow E, Wood JG, Chadwick C, Newall AT, Torvaldsen S, Moen A et al. Global production capacity of seasonal and pandemic influenza vaccines in 2019. Vaccine. 2021;39:512–20. doi:10.1016/j.vaccine.2020.12.018. SEVENTY-FIFTH WORLD HEALTH ASSEMBLY WHA75(24) Agenda item 17.2 28 May 2022 Global Health for Peace Initiative The Seventy-fifth World Health Assembly, having considered the consolidated report by the Director General,1 Recalling that the WHO Constitution recognizes that the health of all peoples is fundamental to the attainment of peace and security, and recalling resolution WHA34.38 (1981), which recognized the role of physicians and other health workers in the preservation and promotion of peace as the most significant factor for the attainment of health for all; Reiterating the commitment of Member States to the 2030 Agenda for Sustainable Development, which emphasized, inter alia, that there can be no sustainable development without peace and no peace without sustainable development; and emphasizing the importance of ensuring healthy lives, promoting well-being for all at all ages, and promoting just, peaceful and inclusive societies; Noting the role of WHO within its mandate as the directing and coordinating authority on international health matters, Decided: (1) to note the report; (2) to request the Director-General to consult with Member States2 and Observers3 on the implementation of the proposed ways forward contained in document EB150/20 on the Global Health for Peace Initiative, and to then develop – in full consultation with Member States2 and Observers,3 and in full collaboration with other organizations of the United Nations system and relevant non-State actors in official relations with WHO – a road map for the Initiative, for consideration by the Seventy-sixth World Health Assembly in 2023 through the Executive Board at its 152nd session. Eighth plenary meeting, 28 May 2022 A75/VR/8 = = = 1 Document A75/10 Rev.1. 2 And, where applicable, regional economic integration organizations. 3 As described in paragraph 3 of document EB146/43. SEVENTY-FIFTH WORLD HEALTH ASSEMBLY A75/24 Provisional agenda item 17.3 12 April 2022 Poliomyelitis Polio transition planning and polio post-certification Report by the Director-General 1. The Executive Board at its 150th session noted an earlier version of this report.1 The present report provides an update on the implementation of the Strategic Action Plan on Polio Transition (2018–2023)2 at the start of 2022, within the context of the coronavirus disease (COVID-19) pandemic. 2. The focus of polio transition is at the country level, and activities gained pace in 2021 with a focus on integration and sustainability. The Secretariat continued to work with the priority countries3 to revise and implement their national plans for polio transition within the context of the COVID-19 pandemic, to sustain the gains of polio eradication, to avoid backsliding on immunization gains, and to strengthen emergency preparedness, detection and response capacities. 3. The Steering Committee on Polio Transition continues to provide strategic guidance and oversight to ensure that polio transition activities are aligned with programmatic and technical priorities. A Joint Corporate Workplan for Polio Transition sets the framework for coordinated action and joint accountability. Despite the challenges posed by the COVID-19 pandemic, 91% of planned deliverables of the 2020–2021 Joint Corporate Workplan were completed or have progressed. The 2021–2022 Workplan reflects the specific priorities of each region, with a strong focus on moving forward the country agendas, resource mobilization, strategic communications and high level advocacy. As of January 2022, 77% of planned deliverables of the 2021–2022 Workplan were on track or had been delivered. 4. The COVID-19 pandemic has once again demonstrated the importance of surveillance, and the role of the polio surveillance network as a building block to strengthen surveillance systems. As a step to reinforce these efforts, the Secretariat has developed a methodology and tools to support countries to accurately plan and budget the appropriate level of financial resources required to sustain and strengthen disease surveillance as part of their national health systems. Under the umbrella of the Universal Health 1 Document EB150/22 and summary records of the Executive Board at its 150th session, ninth meeting, section 5 and tenth meeting, section 2. 2 See document A71/9 and the summary records of the Seventy-first World Health Assembly, Committee A, sixth and eighth meetings (see https://apps.who.int/iris/handle/10665/325993). 3 The 16 global polio transition priority countries by region are: African Region – Angola, Cameroon, Chad, Democratic Republic of the Congo, Ethiopia, Nigeria and South Sudan; South-East Asia Region – Bangladesh, India, Indonesia, Myanmar and Nepal; and Eastern Mediterranean Region – Afghanistan, Pakistan, Somalia and Sudan. Additionally, the Regional Office for the Eastern Mediterranean has prioritized four additional countries (Iraq, Libya, Syrian Arab Republic and Yemen) owing to their fragility and high-risk status. A75/24 2 Coverage Partnership, and complementing existing strategies,1 the aim is to support countries to identify the critical cost components of their surveillance systems and ensure the integration of these costs into their national budgets and strategic plans. The tools were piloted in India and Sudan in 2021. Lessons learned from these pilot countries will inform subsequent implementation. 5. The polio workforce continues to be engaged in COVID-19 vaccination and immunization recovery efforts, which once again shows the value of this workforce for broader public health priorities. According to real-time data collected in the African Region, over 500 polio workers were engaged in COVID-19 vaccination activities across 33 countries during 2021. In the South-East Asia Region, the integrated polio and immunization surveillance networks have taken on key roles in COVID-19 vaccination guideline development, cold chain management, training of health workers and the facilitation of real-time reporting and data management during campaigns. In the Eastern Mediterranean Region, polio personnel have been involved in a wide range of activities, such as recruiting and training vaccinators, developing microplans and conducting surveillance for adverse events following COVID-19 vaccination. These efforts have been comprehensively documented in a recent report on the contributions of the polio network to COVID-19 vaccination and immunization recovery across the three regions. 6. Cross-programmatic integration has further accelerated and is leveraging experience with the pandemic response to build back resilient immunization programmes. The Global Polio Eradication Initiative Strategy 2022–2026 contains a strong commitment to integration, to reach chronically missed “zero-dose” children in key areas. Similarly, the Immunization Agenda 2030 Framework for Action places strong emphasis on coordinated planning, action and monitoring. 7. There is strong recognition of the need to communicate effectively about the risks, benefits and opportunities that polio transition presents to health systems. The Secretariat has developed a strategic communications framework to support advocacy efforts and to better communicate the value of the polio network for the broader health agenda. The implementation of the framework is assisting in fostering greater ownership, especially at the global and regional levels. COUNTRY-LEVEL PROGRESS African Region 8. The certification of the eradication of the wild poliovirus in August 2020 accelerated polio transition in the African Region. The countries of the Region are committed to capitalizing on this achievement to stop the transmission of all types of polioviruses by the end of 2023, and to integrate polio assets into national health systems in order to strengthen broader disease surveillance, outbreak response capacities and immunization services. 9. The Region has a two-phased approach to polio transition: in order to mitigate the ongoing risk of circulating vaccine-derived poliovirus outbreaks, the 10 polio high risk countries in the Region2 will continue to receive support from the Global Polio Eradication Initiative until the end of 2023, with a view to making a full transition as of 2024. The remaining 37 low risk countries have accelerated implementation, and transitioned out of Global Polio Eradication Initiative support in January 2022. In 1 WHO. Immunization Agenda 2030: a global strategy to leave no one behind, Draft Four – 2 April 2020 (https://www.who.int/immunization/immunization_agenda_2030/en/, accessed 11 October 2021). 2 Angola, Cameroon, Chad, Democratic Republic of the Congo, Guinea, Ethiopia, Kenya, Nigeria, Niger, South Sudan. A75/24 3 the low risk countries, the polio assets and infrastructure have been fully integrated into other public health programmes. Lessons learned from these 37 countries will inform implementation in the 10 high risk countries. 10. The Regional Office for Africa has aligned the implementation of polio transition to the outcomes of the functional reviews of the WHO country offices, which respond to the evolving priorities of Member States. Polio transition offers an opportunity to accelerate both the implementation of the functional reviews and the integration of polio functions in a horizontal manner with a primary health care lens. 11. The priority countries of the Region are revising and implementing their national polio transition plans in the context of COVID-19. In Angola, with support from the World Bank and Gavi, the Vaccine Alliance, provincial support teams are being established to ensure the continuity of polio functions, such as active surveillance, case detection and investigation, while monitoring maternal and child health interventions. A mission is planned for 2022 to monitor implementation and provide additional support. In Chad, the transition plan has been revised to align with the COVID-19 context, and a workshop is being planned for its review and validation. In Cameroon, Democratic Republic of the Congo and South Sudan, the plans are being reviewed under the leadership of the national governments. In Ethiopia, a high level advocacy plan is in place to ensure sustainable financing. In Nigeria, a national transition business case has been endorsed by the Interagency Coordination Committee, with a focus on primary health care revitalization, disease surveillance and outbreak response and routine immunization, and plans are in place to mobilize domestic and external resources for its implementation. 12. The Region is placing strong emphasis on high level advocacy to ensure that polio tools, skills and assets are integrated into national health programmes in a sustainable manner. Polio transition was discussed at the seventy-first session of the Regional Committee for Africa, where Member States declared their strong commitment to integrate polio capacities and key functions into their health systems. As a part of these efforts, a scorecard was introduced at the Regional Committee to monitor national progress in surveillance, immunization, outbreak response and polio transition activities. South-East Asia Region 13. The South-East Asia Region has a single integrated network for surveillance and immunization that provides support not only for polio eradication, but also for measles and rubella elimination, surveillance for vaccine-preventable diseases, strengthening immunization and responding to emergencies. The integrated network makes the South-East Asia Region the most advanced among WHO regions in terms of polio transition. The first steps for financial sustainability, including cost sharing and domestic funding, were taken long before polio transition came onto the global agenda. 14. Among the five priority countries, India, which has the largest network in the Region, is implementing its transition plan in line with the outcomes of the 2020 mid-term review. The Government of India has committed domestic resources to support phase 2 of the implementation of the transition plan, which extends the scope of the network to wider public health functions, including emergency response, and measles and rubella elimination, while continuing support to routine immunization. As a step towards aligning the scope of work to future needs and priorities, the national polio surveillance project has been renamed as the national public health support programme. In the other four countries, steps are being taken towards financial sustainability. In Bangladesh, part of the operational costs of the surveillance and immunization medical officers have been included in the government operational plans. This reflects the intention to ensure the long-term financial sustainability of functions, with full transfer to the government planned for 2026. Indonesia and Myanmar have been able to maintain much smaller A75/24 4 networks, though expansion has stalled due to COVID-19. Discussions have been re-initiated with the Government of Nepal to explore the options for sustainable financing. 15. The Region has developed a comprehensive document on the role and contributions of the integrated surveillance network to the COVID-19 response in each of the five polio transition priority countries. Launched at the seventy-fourth session of the Regional Committee for South-East Asia, the report is the first in-depth account of the network’s broader contributions to public health in the region, highlighting its value as a public health good, especially in the context of COVID-19 response and recovery.1 Eastern Mediterranean Region 16. The Eastern Mediterranean Region hosts the two remaining polio-endemic countries, Afghanistan and Pakistan. While reaching eradication remains of utmost importance, the Region is carefully balancing eradication and transition efforts. The regional workplan for polio transition has five workstreams: developing national transition plans in priority countries, operationalizing integrated public health teams, resource mobilization, integrated vaccine-preventable disease surveillance, and coordination and monitoring. 17. The Region hosts many conflict-affected countries that require a risk-based approach to transition. Cross-programmatic integration, with a smooth handover of polio assets to other public health programmes, is equally important. All WHO country offices in the priority countries have conducted a full mapping of their human resources to optimize the use of their workforce, and multi-disciplinary teams have been set up to foster cross-programmatic integration. 18. In this context, the Regional Office for the Eastern Mediterranean is prioritizing the operationalization of integrated public health teams as an interim strategy to sustain essential polio functions and respond to outbreaks and other public health emergencies until they are systematically integrated into national health systems. 19. All priority countries have developed transition/integration plans to be implemented in the form of integrated public health teams. Operationalization began in January 2022. In Somalia, a three-phased plan has been developed that envisions building capacity at the regional and district level to gradually integrate functions into the national health system to strengthen surveillance and primary health care. In Sudan, the transition plan and rollout of the integrated public health teams aims to support strengthening of vaccine-preventable disease surveillance, immunization and early warning response systems. While the integration of functions into the national health system has been delayed due to economic, political, and access challenges, the rollout of integrated public health teams will facilitate implementation. In the other four countries (Iraq, Libya, Syrian Arab Republic and Yemen) with much smaller and integrated polio infrastructures, the objective is to sustain this integration and to ensure programmatic and financial sustainability. In Iraq, polio field presence has been reduced by 33% since 2019 by integrating polio and immunization functions, with efforts being made to strengthen immunization and surveillance while sustaining polio essential functions. In Libya, the acute flaccid paralysis reporting system is already a part of the Early Warning, Alert and Response Network (EWARN) disease surveillance system. In the Syrian Arab Republic, field staff initially recruited for polio eradication have supported numerous health emergencies and immunization activities over the years, and the focus is to ensure sustainability. In 1 NeXtwork – The role and contribution of the integrated surveillance and immunization network to the COVID-19 response in the WHO South-East Asia Region (Bangladesh, India, Indonesia, Myanmar and Nepal). New Delhi: WHO Regional Office for South-East Asia; 2021 (https://apps.who.int/iris/handle/10665/344902, accessed 11 October 2021). A75/24 5 Yemen, the national transition plan foresees the building of national capacity on integrated disease surveillance, alongside strengthening routine immunization and outbreak preparedness and response. BUDGET, PLANNING, RESOURCE MOBILIZATION AND HUMAN RESOURCES Planning and resource mobilization for polio transition within the context of WHO’s Programme budget 2022–2023 20. As part of planning for the development of the programme budget for 2022–2023, the Secretariat conducted a detailed review with each of the six regional offices to cost the essential functions that WHO will support to advance the three key objectives of the Strategic Action Plan. These essential functions were integrated into the appropriate technical outputs and outcomes of the base segment of the proposed programme budget.1 Member States were fully supportive of this strategic shift and approved the Proposed programme budget 2022–2023 at the Seventy-fourth World Health Assembly.2 21. As part of operationalization of the Programme budget 2022–2023, all major offices validated their plans to reflect most recent developments, also in relation to lessons learnt from COVID-19 pandemic and further discussions with the Global Polio Eradication Initiative to best ensure synergies. Adjustments were made where necessary, and the workplans are now fully operational for implementation. 22. The Secretariat is accelerating resource mobilization efforts, aligned with the vision and priorities of the Thirteenth General Programme of Work, 2019–2023. The aim is to ensure continuity of expertise and capacity where it is most needed. With respect to funding, 2022–2023 will be a bridge biennium, with the high risk countries continuing to receive support through the Global Polio Eradication Initiative to preserve core capacities to prevent and respond to polio outbreaks, whereas the low risk countries will receive technical support from the Secretariat to fully integrate polio functions into immunization, disease surveillance, emergency preparedness and response, and primary health care programmes. As a first step, the financial resources required to safeguard essential functions in regions and countries that will no longer receive funding from the Global Polio Eradication Initiative have been secured for 2022. The Secretariat will continue to monitor the needs and gaps, taking the necessary mitigation measures. Resource mobilization to sustain the essential functions is a shared responsibility across the three levels of the Organization, and constitutes an integral part of the discussions of the intergovernmental Working Group on Sustainable Financing. In parallel, the Secretariat is continuing to advocate for domestic resources as the most sustainable long-term strategy to maintain core capacities and essential functions at the country level. Update on human resources 23. The Secretariat continues to monitor the polio programme staffing through a dedicated database. There has been a 53% decrease in the number of filled positions funded by the Global Polio Eradication Initiative since 2016 (Table),3 many of which have been absorbed by other programmes, reflecting the 1 See document A74/5 Rev.1 for more detail on verified final costs for each major office. 2 See resolution WHA74.3 (2021). 3 For more detailed information see the WHO website HR planning and management (https://www.who.int/teams/polio-transition-programme/HR-planning-and-management, accessed 11 October 2021). Annex 1 – WHO staff members funded by the Global Polio Eradication Initiative aggregated by contract type; Annex 2 – WHO staff members funded by the Global Polio Eradication Initiative aggregated in major offices, aggregated by grade and contract type. A75/24 6 implementation of transition plans in regions and countries as they become less at risk for polio. The year 2022 is a major milestone, with 57 countries transitioning from Global Polio Eradication Initiative support; henceforth staff and resources of the Global Polio Eradication Initiative will be concentrated only in the African and Eastern Mediterranean regions, in order to focus on the achievement of the two goals of the Polio Eradication Strategy 2022–2026 by the end of 2023. 24. The African Region, which has the highest number of polio funded staff positions, has taken specific measures to address the impact of the declining financial resources from the Global Polio Eradication Initiative. The Regional Office for Africa has incorporated these essential functions into the implementation of the functional reviews in 47 country offices. The results of this process align with the programmatic needs and priorities of the two-phased transition planned in the Region. The outcomes of the transition will support both the implementation of the functional reviews and the continuation of polio activities in all countries, while balancing the reduction in long-term contracts and organizational liabilities with the need to maintain critical capacity through the use of alternative contractual modalities. Table. Number of polio staff positions supported by the Global Polio Eradication Initiative, by major office (2016–2022) Major office 2016 2017 2018 2019 2020 2021 2022a Variation between 2016 and 2022 Headquarters 77 76 70 72 71 66 71 -8% Regional Office for Africa 826 799 713 663 594 524 297 b -64% Regional Office for South-East Asia 39 39 39 36 36 35 – c -100% Regional Office for Europe 9 8 4 5 4 2 – c -100% Regional Office for the Eastern Mediterranean (majority of positions located in Afghanistan and Pakistan) 155 152 153 170 146 143 152 -2% Regional Office for the Western Pacific 6 6 5 3 3 2 –c -100% Total 1 112 1 080 984 949 854 772 520 -53% a As of January 2022. Source: Global Polio Eradication Initiative global human resource database. b The figures reflect the two-phased transition planned in the African Region. As of 1 January 2022, the Global Polio Eradication Initiative will support only the staff positions in the 10 high risk countries and the Polio Coordination Unit in the Regional Office. All other positions have been transitioned to other programmatic areas. c In the South-East Asia, Europe and Western Pacific regions, staff positions funded from the base budget sources will continue to ensure that polio eradication is sustained in these regions. A75/24 7 MONITORING AND EVALUATION 25. Progress is being regularly monitored through the monitoring and evaluation dashboard, with specific output indicators aligned with the three objectives of the Strategic Action Plan.1 The dashboard has been updated with the three-year time-series of country indicators (2018–2020), and available data from 2021. The regional offices have additional tools to complement the monitoring of programmatic performance. 26. The fifth report of the Polio Transition Independent Monitoring Board2 focuses on increasing interdependence between eradication and transition, making recommendations for actions by programmes to move forward the eradication and transition agendas. The Secretariat is currently outlining a way forward to address the recommended actions , in coordination with Member States and partners. 27. The Strategic Action Plan on Polio Transition (2018–2023) includes a provision for a mid-term evaluation by the WHO Evaluation Office within the polio transition road map that was prepared to support its implementation. This evaluation was also included in the biennial evaluation workplan 2020–2021 approved by the Executive Board at its 146th session in February 2020. The evaluation was conducted by an external independent evaluation team that was selected by the Evaluation Office through an open tender. The evaluation team undertook its main work during the fourth quarter of 2021 and first quarter of 2022, and delivered its report in early April 2022. An executive summary of the evaluation report will be submitted to the Health Assembly.3 ACTION BY THE HEALTH ASSEMBLY 28. The Health Assembly is invited to note the report, and to provide guidance on: (a) accelerating the implementation of country plans in the context of COVID-19, ensuring the financial sustainability of transitioned functions; and (b) mitigating programmatic risks and recognizing opportunities in countries that are transitioning out of support from the Global Polio Eradication Initiative. = = = 1 WHO. Polio transition programme: monitoring and evaluation dashboard. In WHO/Teams [website]. Geneva: World Health Organization; 2021 (https://www.who.int/teams/polio-transition-programme/polio-transition-dashboard, accessed 11 October 2021). 2 Building stronger resilience: the essential path to a polio-free world. Polio Transition Independent Monitoring Board fifth report, December 2021 (https://polioeradication.org/wp-content/uploads/2022/01/5th-TIMB-report-Building- stronger-resilience-20211231.pdf, accessed 22 March 2022). 3 Document A75/INF./7. SEVENTY-FIFTH WORLD HEALTH ASSEMBLY WHA75.18 Agenda item 18.2 28 May 2022 Outcome of the SIDS Summit for Health: For a Healthy and Resilient Future in Small Island Developing States The Seventy-fifth World Health Assembly, Having considered the consolidated report by the Director-General;1 Noting that climate change, a persistent crisis, threatens the health of the people of all Member States, but that the populations of the small island developing States are among the first and hardest hit; Noting also that, besides climate change, small island developing States share grave health and sustainable development challenges posed by the impacts of natural and man-made hazards, environmental degradation, health emergencies, loss of biodiversity, the coronavirus disease (COVID-19) pandemic, external economic shocks, malnutrition, noncommunicable diseases and mental health conditions; Recognizing that small island developing States are disproportionately impacted by climate change, which undermines the progress towards their achievement of the 2030 Agenda for Sustainable Development, including Sustainable Development Goal 3 on good health and well-being; Further recognizing that the vulnerabilities of small island developing States to extreme weather events, including natural and man-made hazards, and other external economic shocks, underscore the importance of strong and resilient health systems, underpinned by universal health coverage, that focus on equitable access, quality, as well as financial protection and financing for development in the era of COVID-19 and beyond; Recalling United Nations General Assembly resolution 69/15 (2014), which set forth the SIDS Accelerated Modalities of Action (SAMOA) Pathway for an accelerated development plan in small island developing States, and General Assembly resolution 70/1 (2015), which adopted the 2030 Agenda for Sustainable Development with the collective aim towards a transformative step for a sustainable and resilient path in ensuring that no one is left behind, and noting the correlation between high levels of vulnerability and impacts on progress towards achieving the Sustainable Development Goals; Recalling also WHO’s Memorandum of Understanding with the United Nations Framework Convention on Climate Change in the margins of the twenty-third session of the Conference of the Parties to the Convention, and the launch of the special initiative to protect people living in small island 1 Document A75/10 Rev.1 (item 18.2, WHO’s implementation framework for Billion 3). WHA75.18 2 developing States and the report submitted to the Seventy-third World Health Assembly in May 2020 on the implementation of the plan; Welcoming the initiative of the Director-General to host the first SIDS Summit for Health: For a Healthy and Resilient Future in Small Island Developing States on 28 and 29 June 2021; Noting with appreciation the outcome statement of the SIDS Summit for Health1 agreed upon by the small island developing States that are Member States of WHO; Noting the actions proposed in the SIDS Summit for Health outcome statement for all partners to small island developing States to guide them in pursuing key actions needed to prevent and respond to the urgent threats faced by small island developing States; Acknowledging the commitments made by the Director-General to pursue the actions requested of the Secretariat in response to the SIDS Summit for Health outcome statement, including on the establishment of a SIDS Leaders Group for Health, and organizing a second SIDS Summit for Health in 2023; Taking note of the SIDS Summit for Health outcome statement, which emphasizes the urgent health challenges and needs of small island developing States with the aim of amplifying small island developing States’ voice, promoting collaborative action and strengthening health and development partnerships and financing, 1. URGES Member States2 to strengthen their collaboration and partnership in support and recognition of the unique vulnerabilities of small island developing States in addressing the various health needs and priorities as highlighted in the SIDS Summit for Health outcome statement and assisting the small island developing States’ response to address persistent health, climate change and development challenges that they encounter including through the implementation of the SIDS Accelerated Modalities of Action (SAMOA) Pathway; 2. CALLS UPON all international, regional and national partners, from within and beyond the health sector, to pursue the actions called for in the SIDS Summit for Health outcome statement and to promote the needs and required actions needed for small island developing States; 3. DECIDES to propose a Voluntary Health Trust Fund for small island developing States with the terms of reference to be tabled, in conjunction with a report from the Secretariat on current practices for funding participation of Member States in WHO meetings, at the Seventy-sixth World Health Assembly in 2023, with a view, inter alia, to facilitate the participation of small island developing States in WHO meetings and to support technical and capacity-building in their favour on issues of direct relevance to their situation and encourage all States and partners to make voluntary contributions to the Voluntary Health Trust Fund for small island developing States; 1 SIDS Summit for Health outcome statement: For a Healthy and Resilient Future in Small Island Developing States (https://cdn.who.int/media/docs/default-source/sids-summit/sids-summit-for-health---final-outcome- statement.pdf?sfvrsn=7a5db89f_5, accessed 13 May 2022). 2 And, where applicable, regional economic integration organizations. WHA75.18 3 4. REQUESTS the Director-General: (1) to continue to pursue the commitments made before and at the SIDS Summit for Health, including: (a) support for the SIDS Leaders Group for Health for high-level advocacy and driving further attention globally on the health challenges and initiatives of the small island developing States and collaboration across Member States and partners; (b) support for the leveraging of improved multisectoral and innovative financing for small island developing States and strengthening platforms to better support small island developing States on urgent health challenges; (c) facilitating greater collaboration for cooperation frameworks with other entities of the United Nations system, Member States1 and partners; (2) to report to the Seventy-seventh World Health Assembly in 2024 on the progress made in implementing this resolution as well as the outcomes of the second SIDS Summit for Health. Eighth plenary meeting, 28 May 2022 A75/VR/8 = = = 1 And, where applicable, regional economic integration organizations. SEVENTY-FIFTH WORLD HEALTH ASSEMBLY WHA75.19 Agenda item 18.2 28 May 2022 Well-being and health promotion The Seventy-fifth World Health Assembly, Having considered the consolidated report by the Director-General;1 Considering the vast implications that current economic, environmental and social conditions have on the health of societies, communities and people and the potential that health promotion, health protection and disease prevention have on enhancing the capacities of people to protect and improve their health and well-being, in addition to health and social measures by governments; Reaffirming that health is a state of complete physical, mental and social well-being, and not merely the absence of disease or infirmity; Reaffirming also, as enshrined in the WHO Constitution, that the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition; Further reaffirming that the objective of WHO shall be the attainment by all peoples of the highest possible level of health; Reaffirming that governments have a responsibility for the health of their peoples, which can be fulfilled only by the provision of adequate health and social measures; Recalling United Nations General Assembly resolution 70/1 (2015) on transforming our world: the 2030 Agenda for Sustainable Development, which identified as part of the new Agenda, that to promote physical and mental health and well-being, and to extend life expectancy for all, we must achieve universal health coverage and access to quality health care, and affirmed that no one must be left behind; Recalling also United Nations General Assembly resolution 67/81 (2012), which recognized that effective and financially sustainable implementation of universal health coverage is based on a resilient and responsive health system that provides comprehensive primary health care services, with extensive geographical coverage, including in remote and rural areas, and with a special emphasis on access to populations most in need, and has an adequate skilled, well-trained and motivated workforce, as well as capacities for broad public health measures, health protection and addressing determinants of health through policies across sectors, including promoting the health literacy of the population; Further recalling the 2008 report of the Commission on Social Determinants of Health and the three overarching recommendations of the Commission: to improve daily living conditions, to tackle 1 Document A75/10 Rev.1 (item 18.2, WHO’s implementation framework for Billion 3). WHA75.19 2 the inequitable distribution of power, money and resources; and to measure and understand the problem and assess the impact of action; Recalling also the Thirteenth General Programme of Work, 2019–2025 and the target of one billion people enjoying better health and well-being by 2025; Building on the legacy of the Ottawa Charter for Health Promotion, 1986 and noting the outcomes of other previous global conferences on health promotion; Acknowledging that the health and well-being of the population is associated with peace, security, stability, improved productivity and economic growth and that socially and economically unfair and largely avoidable inequities within and between countries may have a reverse impact; Noting that health is produced and that it can be endangered in all environments of society, which is why promoting health and well-being requires environmentally and financially sustainable action and investment by multiple sectors of government and input from wider society, including multisectoral engagement with social and economic actors, from individuals, communities, nongovernmental organizations and the private sector; Acknowledging that successful promotion of health and well-being builds on complementary and essential approaches, including: a Health in All Policies approach, emphasizing that public policies and decisions made in policy areas other than health impact citizens’ health and its determinants; a whole- of-government approach, referring to the joint activities performed by diverse ministries, public administrations and public agencies in order to provide common solutions; as well as a whole-of-society approach, stressing the role of participatory governance and partnerships with different non-State actors at all levels, including the private sector, nongovernmental organizations, communities and individuals; Acknowledging also that the promotion of health and well-being can address determinants of health and/or risk factors at population, community, specific group or individual levels and in different contexts, taking into account the specific needs of people in vulnerable situations, including the removal of attitudinal, institutional and environmental barriers encountered by persons with disabilities; Noting the increasing impact on premature mortality from noncommunicable diseases, the continued burden caused by communicable diseases and the new demands they both put on governments in the protection and promotion of health in order to achieve health equity and ensuring universal health coverage; Emphasizing that in order to have capacity for health-informed decisions and health-seeking behaviours individuals must have achieved an appropriate level of health literacy; Stressing that the development of interventions at population, community and individual levels to further increase health literacy and improve health outcomes must be guided by evidence, in particular from social and behavioural science, with consideration given to using innovative approaches, communication channels and technologies; Noting that many persons with disabilities, particularly girls and women, face barriers in accessing information and education, including with regard to sexual and reproductive health and reproductive rights as agreed in accordance with the Programme of Action of the International Conference on Population and Development and the Beijing Platform for Action and the outcome documents of their review conferences as adopted by the United Nations General Assembly; WHA75.19 3 Recalling that multisectoral action on social, environmental and economic determinants of health, for the entire population and proportionate to the level of disadvantage of people in vulnerable situations, is essential to create inclusive, equitable, economically productive, resilient and healthy societies with healthy environments that make healthy options the easy options to choose; Acknowledging the importance of national, international and global cooperation and solidarity for the equitable benefit of all people and the important role that relevant multilateral organizations, under the leadership of WHO, have in articulating and promoting norms and guidelines and identifying and sharing good practices for supporting actions on social, environmental and economic determinants of health; Considering that positioning human health and well-being as one of the key features of what constitutes a successful, inclusive and fair society in the 21st century is consistent with our commitment to human rights at national, regional and international levels, 1. URGES Member States: (1) to strengthen health promotion and disease prevention through high-impact public policies, based on scientific evidence and best available knowledge, across sectors, developed through participatory processes; to strengthen health systems and to address health determinants and reduce risk factors, including through appropriate regulation; and to use health and health equity impact assessments in their development in order to achieve equitable outcomes; (2) to strengthen the health system and empower the health workforce, including by base and continuous training, in the provision of health promotion, disease prevention and health communication at all levels of health services, including by using innovative approaches, communication channels and technologies, ensuring that people in vulnerable situations have access to information; (3) to develop enabling environments conducive to health by addressing determinants of health across sectors and by reducing risk factors and thus make it easier for individuals to make healthy choices to support the realization of healthy, safe and resilient communities; (4) to accelerate efforts to ensure healthy lives and promote well-being and universal health coverage by 2030 for all throughout the life course, and in this regard re-emphasize our resolve to cover one billion additional people by 2025 with quality essential health and mental health services, quality, safe and effective essential medicines, vaccines, diagnostics and health technologies, and essential and quality health information, with a view to cover all people by 2030; (5) to ensure the implementation of country- and context-specific essential public health functions to protect and promote health and to prevent diseases; (6) to ensure universal access to sexual and reproductive health care services, including for family planning, information and education, and the integration of reproductive health into national strategies and programmes; (7) to consider taking steps to include basic health knowledge in curricula to ensure that everybody has an appropriate level of health literacy and implement effective, high-impact, quality-assured, people-centred, gender-, disability- and health literacy-responsive, WHA75.19 4 equity-oriented and evidence-based interventions, mindful of cultural contexts to meet the health needs of all throughout the life course, and in particular of persons with disabilities and people in vulnerable situations, ensuring universal access to nationally determined sets of integrated quality health services at all levels of care for health promotion, disease prevention, diagnosis, treatment and care, and rehabilitation in a timely manner, including promoting return-to-work programmes; (8) to support establishment, as appropriate, of mechanisms for generating, gathering and sharing evidence for developing high-impact policies to promote and protect people’s physical, mental and social well-being and comprehensively address structural, social, economic, environmental and other determinants of health by working across all sectors through a whole-of-government, whole-of-society and Health in All Policies approach; (9) to consider, as appropriate, establishing governmental, regional, subregional and local structures responsible for population-level health promotion, with sustainable financing, and continuous reporting; and to strengthen population-based health promotion implementation and ensure its resilience; (10) to promote health and well-being through coordinated and multisectoral action throughout the life course and by providing conditions for people to access and enjoy clean and safe water, healthy food from sustainable food systems, clean air, tobacco-free environments and social participation, free from all forms of discrimination and inequalities and where all people are able and empowered to take responsibility for their own health and well-being; (11) to design and orient public systems and infrastructures, including health systems that serve people’s needs, that are accessible and affordable to all to ensure health equity contributing to sustainable and resilient economic development; 2. REQUESTS the Director-General: (1) to develop, within the mandate of WHO, a framework on achieving well-being, building on the 2030 Agenda for Sustainable Development with its 17 Sustainable Development Goals and identify the role that health promotion plays within this, in consultation with Member States, for consideration by the Seventy-sixth World Health Assembly in 2023, through the Executive Board at its 152nd session; (2) to develop as part of that framework an implementation and monitoring plan that includes identifying and supporting the translation into practice of innovative approaches for well-being using health promotion tools, new technologies and approaches to contribute to the WHO general programme of work; (3) to provide technical support to Member States in strengthening their governance, financing, human resources, evidence generation, data disaggregation and research structures for well-being and health promotion; (4) to promote and recommend scientifically sound interdisciplinary research to develop the evidence base for interventions for the promotion of health and well-being at population, community and individual levels, including by using big data, building on the measurement systems of the Sustainable Development Goals; WHA75.19 5 (5) to report on the implementation of this resolution to the Seventy-seventh World Health Assembly in 2024, the Seventy-ninth World Health Assembly in 2026 and the Eighty-fourth World Health Assembly in 2031, through the relevant sessions of the Executive Board. Eighth plenary meeting, 28 May 2022 A75/VR/8 = = = SEVENTY-FIFTH WORLD HEALTH ASSEMBLY WHA75(22) Agenda item 18.2 28 May 2022 WHO global strategy for food safety The Seventy-fifth World Health Assembly, having considered the consolidated report by the Director-General,1 Decided: (1) to adopt the updated WHO global strategy for food safety; (2) to call on Member States to develop national implementation road maps or reflect actions to implement the strategy within existing food safety policies and programmes and to make appropriate financial resources available to support such work; (3) to request the Director-General to report on progress in the implementation of the updated WHO global strategy for food safety to the Seventy-seventh World Health Assembly in 2024 and thereafter every two years until 2030. Eighth plenary meeting, 28 May 2022 A75/VR/8 = = = 1 Document A75/10 Rev.1. SEVENTY-FIFTH WORLD HEALTH ASSEMBLY WHA75(23) Agenda item 18.2 28 May 2022 Reducing public health risks associated with the sale of live wild animals of mammalian species in traditional food markets – infection prevention and control The Seventy-fifth World Health Assembly, having considered the consolidated report by the Director-General,1 Decided to request the Director-General: (1) to update the interim guidance on reducing public health risks associated with the sale of live wild animals of mammalian species in traditional food markets in order to answer questions on the scope of the guidance, including the species that the guidance covers (mammalian species or mammalian species plus other species) and farmed or wild live animals; (2) to develop plans to support country implementation of the interim guidance on reducing public health risks associated with the sale of live wild animals of mammalian species in traditional food markets – infection prevention and control; (3) to report on progress made in updating the interim guidance on reducing public health risks associated with the sale of live wild animals of mammalian species in traditional food markets – infection prevention and control and the country support plans to the Seventy-seventh World Health Assembly in 2024 and thereafter every two years until 2030, in parallel with reporting on the progress in implementing the WHO global strategy for food safety. Eighth plenary meeting, 28 May 2022 A75/VR/8 = = = 1 Document A75/10 Rev.1. SEVENTY-FIFTH WORLD HEALTH ASSEMBLY A75/29 Provisional agenda item 21.4 25 April 2022 Prevention of sexual exploitation, abuse and harassment Report by the Director-General 1. This report provides an update of the actions taken by the Secretariat in response to decision EB148(4) (2021) on preventing sexual exploitation, abuse and harassment, adopted by the Executive Board at its 148th session, as well as the broader steps taken to strengthen the Organization’s efforts to address this matter during the period June 2021 to February 2022. An earlier version of this report was considered by the Executive Board at its 150th session in January 2022.1 At that session, the Board adopted decision EB150(23), in which it decided to suspend Financial Rule XII, 112.1 in order to support investigations of sexual exploitation and abuse or abusive conduct. 2. Two significant events influenced the progress of WHO’s work in this area during the period under review: the establishment by the Director-General of dedicated core capacity in the Secretariat to coordinate the work on prevention of and response to sexual exploitation and abuse and sexual harassment; and the publication of the management response to the report of the Independent Commission to investigate allegations of sexual exploitation and abuse during the tenth outbreak of Ebola virus disease in the provinces of North Kivu and Ituri, the Democratic Republic of the Congo.2 3. On 1 July, 2021, the Director-General initiated steps to build capacity to urgently implement the institutional changes needed to strengthen effective prevention of and response to sexual exploitation and abuse and sexual harassment across the Organization by appointing a Director ad interim for the matter, reporting directly to him. He also established an Organization-wide task team currently comprising 38 senior officials from all accountability and enabling functions, the WHO Health Emergencies Programme, the Senior Advisor on Gender, the Office of the Ombudsman, the Global Polio Eradication Programme and representatives of each of the six Regional Directors drawn from different functions, including Heads of WHO country offices. Since August 2021 the task team developed, and has been implementing, a workplan that encompasses actions to address prevention and response, aligned with actions requested in decision EB148(4), as well as promoting best practice drawn from across the United Nations system and the development and humanitarian sectors. 4. The report of the Independent Commission to investigate allegations of sexual exploitation and abuse during the tenth Ebola virus disease outbreak in the provinces of North Kivu and Ituri, the 1 Documents EB150/33 and EB150/33 Add.1. 2 WHO. Preventing & responding to sexual exploitation and abuse: WHO management response to the Report of the Independent Commission to investigate allegations of sexual abuse and exploitation during the response to the 10th Ebola Virus Disease epidemic in the provinces of North Kivu and Ituri, the Democratic Republic of the Congo, of 28 September 2021. Geneva: World Health Organization; 2021 (https://cdn.who.int/media/docs/default-source/ethics/who- management-response-20211020-finalv2.pdf?sfvrsn=591a9adf_12&download=true, accessed 29 March 2022). A75/29 2 Democratic Republic of the Congo, issued on 28 September 2021,1 concluded that: sexual exploitation and abuse happened in the context of the response to that outbreak and the Organization did not take adequate actions to prevent it, actions that included conducting a comprehensive risk assessment, putting in place preventive measures, enabling outreach to local populations and reporting of incidents from the outset of the emergency operations; and that there was a failure or lack of mechanisms in the Organization to identify and appropriately address potential opportunities for or instances of sexual exploitation and abuse. The Independent Commission’s report made recommendations in eight areas, some of which were specific to the country and others which were applicable to WHO overall. The Secretariat has been transparent in its communication of the report with all key stakeholders: Member States, staff members, media, the public and representatives of the alleged victims and survivors. The release of the report was accompanied by a rapid and comprehensive consultation with Member States, all regional offices and senior managers in the Organization so as to facilitate the drafting of the WHO Management Response Plan.2 The Plan and its accompanying implementation plan3 have been posted on WHO’s website to ensure continued transparency and accountability, and are now being implemented. An update to the Implementation plan was published in March 2022.3 A UNIFIED FRAMEWORK FOR WORK ON PREVENTION OF AND RESPONSE TO SEXUAL EXPLOITATION AND ABUSE AND SEXUAL HARASSMENT 5. The WHO Management Response Plan presents a unified framework that outlines WHO’s actions to respond to all recommendations made in the Independent Commission’s report, implement decision EB148(4), respond to recommendations made in the report of the Independent Oversight and Advisory Committee for the WHO Health Emergencies Programme’s Subcommittee for the Prevention and Response to Sexual Exploitation, Abuse and Harassment4 and promote best practices from other entities in the United Nations system and nongovernmental organizations. The Plan brings together the Organization’s work on prevention of and response to sexual exploitation and abuse and its efforts to implement its policies and procedures on addressing abusive conduct.5 It dovetails with the many Organization-wide actions under the Respectful Workplace Initiative. The Plan is a living document and will be implemented in two phases. It addresses the recommendations of the Independent Commission and lays the foundation for effective work while a longer-term strategy is developed for the period 2023‒2025. It will contribute towards reaching the goals of zero tolerance for sexual exploitation and abuse and sexual harassment, and for inaction in preventing and addressing it. 1 Independent Commission on Allegations of Sexual Exploitation and Abuse during the Response to the 10th Ebola Outbreak in DRC. Final Report of the Independent Commission on the review of sexual abuse and exploitation during the response to the 10th Ebola virus disease epidemic in DRC. Geneva: World Health Organization; September 2021 (https://www.who.int/publications/m/item/final-report-of-the-independent-commission-on-the-review-of-sexual-abuse-and- exploitation-ebola-drc, accessed 29 March 2022). 2 WHO Management Response Plan: meeting report. Geneva: World Health Organization; 2021 (https://www.who.int/publications/m/item/who-management-response-plan, accessed 29 March 2022). 3 Implementation Plan (IP) of the WHO Management Response to the Report of the Independent Commission to investigate allegations of sexual abuse and exploitation during the response to the 10th Ebola Virus Disease epidemic in the provinces of North Kivu and Ituri, the Democratic Republic of the Congo. Geneva: World Health Organization; Version 2, March 2022. (https://www.who.int/publications/m/item/who-implementation-plan, accessed 29 March 2022). 4 Document EB150/34. 5 WHO. Policy: Preventing and Addressing Abusive Conduct: Policy and Procedures Concerning Harassment, Sexual Harassment, Discrimination, and Abuse of Authority. Geneva: World Health Organization; 2021. (https://www.who.int/publications/m/item/preventing-and-addressing-abusive-conduct, accessed 29 March 2022). A75/29 3 6. In the short term (mid-October 2021 to March 2022), the Management Response Plan has prioritized: complementing the investigation of the allegations of sexual exploitation and abuse outlined in the Independent Commission’s report with assistance from the United Nations Office for Internal Oversight Services; conducting an investigation into alleged professional negligence by WHO personnel; ensuring support is provided to survivors and victims of sexual exploitation and abuse and sexual harassment perpetrated by WHO personnel; conducting an audit of the management of cases by WHO’s accountability functions; and mobilizing WHO’s entire workforce for the implementation of the Plan. 7. To put these actions into operation, the Secretariat has agreed with the Independent Expert Oversight and Advisory Committee that the latter will oversee the implementation of the recommendations of the implementation plan, which include the recommendations of the Independent Commission. WHO has contracted an independent supplier to undertake an audit of the Secretariat’s case management of allegations and complaints of sexual exploitation and abuse and sexual harassment. The audit will cover all allegations and complaints of sexual exploitation and abuse and sexual harassment, together with a random sample of allegations and/or complaints of harassment, received by the Compliance, Risk Management and Ethics Department or the Office of Internal Oversight Services of the Secretariat during the period 1 August 2018 to 30 September 2021. The audit will also be overseen by the Independent Expert Oversight and Advisory Committee. In addition, WHO and the United Nations Office for Internal Oversight Services have agreed that the latter will complement the investigations conducted by the Independent Commission and its external investigative team in order to positively identify additional alleged perpetrators, in compliance with WHO’s investigative requirements and, under the oversight of the Independent Expert Oversight and Advisory Committee, to review whether there has been failure on behalf of WHO’s management to initiate investigative processes where warranted. 8. WHO is using the “Clear Check” screening database, which is a centralized database that permits the sharing of information amongst United Nations entities on former United Nations staff members with records of sexual exploitation and abuse or sexual harassment, with the aim of preventing their re- employment within the United Nations system. WHO enters the names and details of former WHO staff members against whom allegations of sexual exploitation and abuse or sexual harassment have been confirmed and, under certain conditions, former personnel who are the subject of pending allegations of sexual exploitation and abuse or sexual harassment. Where applicable, this includes the names of alleged perpetrators identified in the report of the Independent Commission. By end February 2022 a total of 14 names of alleged perpetrators from the report had been entered into the database. The use of the database to vet individuals considered for employment, engagement or deployment by the Organization is being extended across the Organization. For example, it was used to screen personnel deployed during the thirteenth outbreak of Ebola virus disease in the Beni Health Zone in North Kivu Province of the Democratic Republic of the Congo in October 2021, and to complete the vetting of all the polio experts in the database of 2400 staff members. Additionally, in December 2021, all WHO staff members were vetted against the Clear Check database. 9. Concerning victim and survivor support, in November 2021 WHO and UNICEF jointly led an Inter-Agency Standing Committee’s Mission to Goma and Kinshasa, Democratic Republic of the Congo, with representatives from the United Nations Population Fund (UNFPA) and the United Nations Office of the Victims’ Rights Advocate. Members of the mission team met with various stakeholders, including the humanitarian country team, partner agencies, government officials, nongovernmental and community-based organizations, victims and survivors, and donor organizations. The objectives of the mission included the implementation of relevant actions from WHO’s Management Response Plan, assessment of progress made since the previous mission of the Inter-Agency Standing Committee a year A75/29 4 before, and formulation of recommendations for the further strengthening of work on preventing and responding to sexual exploitation and abuse and sexual harassment in the country. 10. The mission also advanced support to victims of sexual exploitation and abuse from the tenth Ebola virus disease outbreak in the Democratic Republic of the Congo and the finalization of a memorandum of understanding between WHO and UNFPA to ensure that all victims and survivors receive the support they need. WHO has provided the funding required to support 92 victims and survivors of actions perpetrated by individuals identified by the Independent Commission, as well as the children born as a result. The Secretariat mapped the services already accessed by the victims, using data provided by UNFPA and the Office of the Victims’ Rights Advocate. The memorandum of understanding covers activities, funded by WHO and implemented under the supervision of UNFPA, to assess the current medical, psychological, legal, socioeconomic and reintegration needs of victims and survivors and to examine the needs of children born as a result of sexual exploitation and abuse. WHO is collaborating with a well-established, women-led legal aid nongovernmental organization in the country to ensure that the victims who want to pursue legal action are supported to do so. Initially, this nongovernmental organization will be contracted to provide full legal aid to up to 25 victims and survivors of sexual exploitation and abuse in 2022. The Secretariat will in addition support integrated and holistic services for victims through nongovernmental organizations, including HEAL Africa. The United Nations humanitarian country team is developing a standard framework for victim-support services and the Secretariat will align with this framework once it is validated by the Office of the Victims’ Rights Advocate. Members of the mission also met: the Provincial Governor of North Kivu in Goma; the national Minister of Public Health, Hygiene and Prevention in Kinshasa to discuss government action related to sexual exploitation and abuse and sexual harassment and the newly-formed National Commission on the subject; the Vice-Minister of Public Health, Hygiene and Prevention to discuss the strengthening of referral services for gender-based violence that any victim can access; and the Minister of Gender, Family and Children for scaling up protection and legal aid for victims of gender-based violence and sexual exploitation and abuse. 11. In the medium term (November 2021 to December 2022) WHO’s Management Response Plan seeks: to define, internalize and operationalize a victim- and survivor-centred approach to preventing and responding to sexual exploitation, abuse and sexual harassment across the Organization; to develop and enforce an accountability framework for all personnel that is accompanied by training and building capacity and outlining enhanced responsibilities for supervisors, managers and senior managers; and to reform WHO’s culture, structures, policies, processes and practices to enable effective work in the area. A three-year Organization-wide strategy for the period 2023‒2025 on tackling sexual exploitation, abuse and sexual harassment will be a major longer-term result of the Management Response Plan. 12. By the end of March 2022, 86% of activities in the Management Response Plan had been completed or were in progress. Additionally, all the inputs provided during the relevant agenda items of the 150th session of the Executive Board, along with recommendations from the report of the Independent Oversight and Advisory Committee for the WHO Health Emergencies Programme’s Subcommittee for the Prevention and Response to Sexual Exploitation, Abuse and Harassment had been integrated into the Management Response Plan, to maintain a single unified framework for the prevention of and response to sexual exploitation and abuse and sexual harassment across WHO. INSTITUTIONAL CAPACITY FOR PREVENTION, DETECTION AND RESPONSE TO SEXUAL EXPLOITATION AND ABUSE AND SEXUAL HARASSMENT 13. Strong leadership is essential to achieve zero tolerance for sexual exploitation and abuse and sexual harassment. The Director-General and the six Regional Directors lead the Organization’s work A75/29 5 on the matter. A new WHO public website on the subject was launched in July 2021, providing easy access to key documents, including the report of the Independent Commission, the Management Response Plan, the implementation plan and a monthly newsletter on progress, which promotes greater transparency and accountability.1 14. A comprehensive review of WHO’s relevant policies and procedures has been launched to identify gaps and inconsistencies in relation to the WHO regulatory framework as well as with regard to existing best practice in this area and to address specific concerns identified in the findings of the Independent Commission. In the interim, WHO’s new Policy Directive on protection from sexual exploitation and sexual abuse came into effect on 3 December 2021 with the aim of clarifying and aligning with the key elements of the United Nations Secretary-General’s Bulletin 2003/13, including definitions of sexual exploitation and abuse,2 as well as the Inter-Agency Standing Committee core principles3 and minimum operating standards4 and the clause on the subject recently adopted by WHO and 15 donor Member States. The Directive also aligns with the United Nations protocol on assistance to victims of sexual exploitation and abuse5 and the United Nations protocol on allegations of sexual exploitation and abuse involving implementing partners.6 15. As set out in the Management Response Plan, the Secretariat is making progress towards creating a comprehensive, up-to-date, easy-to-use policy framework that will consolidate all relevant revised policies, accompanied by procedures and implementation guidance. An information note on the Policy Directive on Protection from sexual exploitation and abuse was issued in December 2021.7 In 2022, the focus is on revising and updating the WHO code of Ethics and Professional Conduct. 16. WHO’s Policy on Preventing and Addressing Abusive Conduct,8 which covers sexual harassment in addition to other forms of harassment, discrimination and abuse of authority, came into effect on 1 WHO. Preventing and responding to sexual exploitation, abuse and harassment. Geneva: World Health Organization; 2021 (https://www.who.int/initiatives/preventing-and-responding-to-sexual-exploitation-abuse-and- harassment, accessed 29 March 2022). 2 United Nations Secretariat. Secretary-General’s Bulletin: special measures for protection from sexual exploitation and sexual abuse. Document ST/SGB/2003/13. New York: United Nations; 2003 (https://www.securitycouncilreport.org/un- documents/document/se-st-sgb-2003-13.php, accessed 29 March 2022). 3 Inter-Agency Standing Committee. IASC six core principles relating to sexual exploitation and abuse, 2019. New York: United Nations; 2019 (https://interagencystandingcommittee.org/inter-agency-standing-committee/iasc-six-core- principles-relating-sexual-exploitation-and-abuse, accessed 29 March 2022). 4 Inter-Agency Standing Committee. Minimum operating standards (MOS-PSEA). New York: United Nations; 2016 (https://interagencystandingcommittee.org/iasc-task-team-accountability-affected-populations-and-protection-sexual- exploitation-and-abuse/minimum-operating-standards-mos-psea, accessed 29 March 2022). 5 United Nations Protocol on the Provision of Assistance to Victims of Sexual Exploitation and Abuse. New York; United Nations; 2019 (https://www.un.org/en/pdfs/UN%20Victim%20Assistance%20Protocol_English_Final.pdf, accessed 29 March 2022). 6 United Nations Protocol on Allegations of Sexual Exploitation and Abuse involving Implementing Partners. New York; United Nations (https://psea.interagencystandingcommittee.org/sites/default/files/UN%20Protocol%20on%20SEA%20Allegations%20invol ving%20Implementing%20Partners.pdf, accessed 29 March 2022). 7 WHO Information on Policy Directive on Protection from sexual exploitation and sexual abuse (SEA), Information note, 6 December 2021 (https://cdn.who.int/media/docs/default-source/ethics/information-on-policy-directive-on-protection- from-sexual-exploitation-and-sexual-abuse-.pdf?sfvrsn=8926f2fa_19&download=true, accessed 29 March 2022). 8 WHO. Preventing and addressing abusive conduct: Policy and procedures concerning harassment, sexual harassment, discrimination, and abuse of authority. Geneva: World Health Organization; 2021 (https://www.who.int/publications/m/item/preventing-and-addressing-abusive-conduct, accessed 31 March 2022). A75/29 6 1 March 2021. The policy, which revised and updated the Organization’s previous harassment policy, strengthens the coherence of the complaints process, while taking into account the need to pay particular attention to claims and allegations relating to sexual harassment. Its accompanying implementation plan includes the dissemination of new communication materials and resources for the workforce; the creation of guidance tools for managers and supervisors; the development and delivery of new training sessions tailored to the needs of different audiences; and the updating of related human resources instruments and processes. Particular emphasis is being placed on ensuring that the necessary training and other forms of support are in place across the Organization. Moreover, a system has been established to ensure the implementation of the policy’s prevention measures in all offices. In addition, the recently established Prevention and Response to Sexual Misconduct department is coordinating efforts to build institutional capacity to ensure the effective prevention of and response to sexual harassment. 17. The Secretariat’s core capacity to receive and investigate complaints and allegations of sexual exploitation and abuse and sexual harassment is being strengthened. A Head of Investigations ad interim was appointed in November 2021 to focus on sexual misconduct cases and strengthen the specialized expertise needed to handle such cases effectively and efficiently within WHO. In addition, the reporting hotline (the “Integrity Hotline”) was moved into the Investigations unit and is being streamlined. Safe and accessible reporting mechanisms that incur no fear of retaliation are essential for both the WHO workforce and the communities that the Organization serves, and will be essential to building trust and countering perceptions of impunity for perpetrators of sexual exploitation and abuse and sexual harassment. As such, the Secretariat is reviewing the internal reporting mechanisms and the entire process from suspicions, raising alerts, complaints, investigations to administrative actions as a whole, informed by an independent external audit. The Secretariat will report aggregate figures to Member States on a quarterly basis. 18. Decision EB150(23), containing the provision requiring the temporary suspension of Financial Rule XII, 112.1, provides the Head, Investigations with the authority for all investigations of sexual exploitation and abuse, sexual harassment and other abusive conduct covered under the WHO Policy on Preventing and Addressing Abusive Conduct. In this capacity the Head, Investigations has the same reporting lines, the same type of access, the same channels for reporting the results of work undertaken, including to the Executive Board, and the same authority as those currently granted to the Director, Internal Oversight Services in this area. This has allowed for increased effectiveness and efficiencies in the management of sexual exploitation and abuse and sexual harassment investigations. The backlog of cases relating to sexual exploitation and abuse and sexual harassment has been addressed, with all cases either assigned or completed. In addition, all outstanding harassment cases are being assigned. Efforts will be made to investigate all new cases of sexual exploitation and abuse and sexual harassment within a period of 120 days. A new, globally dispersed team of 15 experts in conducting sexual misconduct investigations, has been established (70% of the team is composed of women). A victim and survivor- centred approach has been introduced into case management and case investigation. The WHO Survivor Assistance Fund has been used in countries to provide immediate and urgent medical and psychosocial support for alleged victims, and for such logistics as their transport to locations where services can be accessed. 19. Although progress is being made, and the increasing numbers of complaints suggest that trust in the system is being strengthened, the institutional capacity for investigation of sexual exploitation and abuse and sexual harassment remains fragile. Several measures are required to achieve stability and sustainability. As per recommendation 2.2 of document EB150/34, the Report of the Independent Oversight and Advisory Committee for the WHO Health Emergencies Programme’s Subcommittee for the Prevention and Response to Sexual Exploitation, Abuse and Harassment, a dedicated and independent unit within the Office of Internal Oversight Services at headquarters has been established to investigate allegations of sexual exploitation and abuse and sexual harassment. Investigations are A75/29 7 conducted confidentially, and are sensitive to the capacities, rights and needs of survivors and communities, taking into account age, gender, sex, disability, ethnicity/race, language and socioeconomic status and other characteristics. 20. The Secretariat has completed a review of United Nations agency and inter-agency sexual exploitation and abuse risk assessment tools and guidance. While working with the United Nations country team and humanitarian country team joint risk assessments where they exist, WHO has prioritized the need to develop an agency-specific risk assessment tool for sexual exploitation and abuse and sexual harassment. Such a tool would allow monitoring and management of sexual exploitation and abuse and sexual harassment risk in all countries where WHO is operational. It would also support accountability and compliance with relevant policies, procedures and practices. The tool will be used to conduct an annual assessment in every country of the prevailing risk resulting from factors within the country: risks of sexual exploitation and abuse and sexual harassment in country offices and in all operations and programme activities that are community-facing. It will include a compliance checklist to be completed by each Head of WHO country offices to reduce sexual exploitation and abuse and sexual harassment risks. The Secretariat will test and pilot the tool in several priority countries in 2022 before integrating it into the Organization’s broader enterprise-wide risk management framework. Furthermore, the reporting on relevant control measures will be fully integrated into the questionnaire accompanying the annual internal control self-assessment checklist. 21. The request for an initial core budget of US$ 50 million allocated to work on preventing and responding to sexual exploitation and abuse and sexual harassment for the biennium 2022‒2023 has been included in the proposed revision of the Programme budget 2022–2023. Additional resources will need to be mobilized for prevention, detection and response activities in field operations and community-facing programmes. As at the end of February 2022 WHO had a network of more than 60 country focal points on the subject in 30 countries, who are being supported with capacity-building and training activities. Guidance has been developed and disseminated to all Heads of WHO country offices to assign a prevention of and response to sexual exploitation and abuse and sexual harassment focal point in every country office. The allocation of the programme portion of the funds for the implementation of the Management Response Plan, amounting to approximately US$ 30 million, will be made with country impact in mind, with 46% of the funds being allocated to country offices, 18% to regional offices, 13% to headquarters and 23% to cross-Organization activities for all levels of the Organization, including a victims’ assistance fund. Approximately US$ 10 million will be allocated to creating strong institutional capacity for investigation services for sexual exploitation and abuse and sexual harassment and other forms of abusive conduct, and the remainder for reforming, streamlining and strengthening related accountability functions across the Organization. Guidance has been drafted outlining 10 core activities for preventing and responding to sexual exploitation and abuse and sexual harassment at country level and the global team is supporting regional offices to include these and related budgeting into public health and health emergency programmes and initiatives. TACKLING SEXUAL EXPLOITATION AND ABUSE AND SEXUAL HARASSMENT IN HIGH-RISK SETTINGS 22. Sexual exploitation and abuse can happen in any setting, but the risk is significantly increased during health emergencies and in any programme that brings WHO personnel into direct contact with communities in need of assistance. WHO is prioritizing interventions to prevent sexual exploitation, and abuse and sexual harassment as its primary strategy, while scaling up detection and response operations across the WHO Health Emergencies Programme and at operational level. WHO’s prevention and response capacities, especially in high-risk settings, including the polio eradication programme, is being strengthened in several ways. Due to the increased risk of sexual exploitation and abuse and sexual A75/29 8 harassment, and its specific characteristics, steps have been taken to fully embed prevention of and response to sexual exploitation and abuse and sexual harassment interventions into the WHO Health Emergencies Programme and in emergency operations. To this end, a cell on preventing and responding to sexual exploitation and abuse and sexual harassment has been established within the Programme and is responsible for overseeing integration of policies and recommendations into emergency operations. The cell interacts and works closely with the relevant programmes and units at headquarters and in the regions, to support countries’ efforts to operationalize the prevention of and response to sexual exploitation and abuse and sexual harassment policies in emergency settings and operations, while engaging with other relevant agencies and stakeholders. 23. As part of embedding prevention of and response to sexual exploitation and abuse and sexual harassment in WHO emergency operations, a range of interventions are being streamlined and integrated into graded emergency response operations. These include: • embedding a prevention of and response to sexual exploitation and abuse and sexual harassment technical expert within the Incident Management Response Team for the event; • ensuring that a plan of action, informed by a risk and capacity assessment is integrated within the emergency response framework, response strategy and budget, advocacy and resource mobilization plan; • implementing recruitment and pre-deployment safeguarding measures, including screening through Clear Check, signing a code of conduct, ensuring that a prevention of sexual exploitation and abuse and sexual harassment clause is inserted in all contracts, and that all staff members undertake mandatory prevention of and response to sexual exploitation and abuse and sexual harassment training, including in induction and refresher training courses; • working with other partners to streamline reporting and referral pathways, build capacities for service provision to survivors and victims of sexual exploitation and abuse, enhance community awareness and engagement on rights and services as components of the prevention of sexual exploitation and abuse network plan of actions, where prevention of sexual exploitation and abuse network partners are in existence. 24. Many of these measures were implemented during the thirteenth Ebola virus disease outbreak response; and are currently being implemented in the north-eastern Ethiopia crisis response, the response to Lassa fever outbreak in Nigeria, the response to flooding in Malawi, and will become be applied systematically within the WHO Health Emergencies Programme. All funding requests for preliminary emergency response operations benefitting from the WHO Contingency Fund for Emergencies are required to include a budget line on prevention of and response to sexual exploitation and abuse and sexual harassment, with clearly articulated activities for implementation during the initial response period. At least 10 requests for Contingency Fund for Emergencies funding in 2022 thus far have responded to this requirement. Notable examples include: WHO responses to disease outbreaks in Cameroon, Nigeria and Afghanistan; flooding in South Sudan and Madagascar; conflict in Ukraine; civil unrest in Sudan; COVID-19 in Guinea and Sierra Leone; and to flooding and poliomyelitis in Malawi. In the Democratic Republic of the Congo, WHO contributed to the joint operational review of prevention of and response to sexual exploitation and abuse and sexual harassment measures post containment of the thirteenth Ebola virus disease outbreak. This approach, with its enhanced focus on embedding prevention of and response to sexual exploitation and abuse and sexual harassment in all emergency operations, must be allocated adequate funding and sufficient human resource capacities, if it is to be sustained. A75/29 9 25. The review of prevention of and response to sexual exploitation and abuse and sexual harassment during the thirteenth outbreak of Ebola virus disease in the Beni Health Zone in the Democratic Republic of the Congo showed that several safeguarding measures had been undertaken by the humanitarian community, including the subregional Inter-Agency Standing Committee coordinator responsible for this area of work, whose position is funded by WHO. These measures included screening by WHO of all personnel deployed for the response through the Clear Check database, the training of responders including governmental and national responders, the assignment of a government focal point for prevention of and response to sexual exploitation and abuse and sexual harassment, the sensitization of communities regarding standards of behaviour to expect from responders, and the establishment of community-based complaint mechanisms linked to the national hotline. 26. The measures and interventions outlined as part of embedding the prevention of and response to sexual exploitation and abuse and sexual harassment in WHO emergency programmes will inform the development of a plan of action for emergency contexts, aligned with the global efforts and policy framework, and the finalization of the WHO’s Emergency Response Framework. 27. The WHO Health Emergencies Programme and the polio eradication programme and the Prevention and Response to Sexual Misconduct department are establishing full-time capacity for prevention of and response to sexual exploitation and abuse and sexual harassment, using a risk-based approach. New staff positions have been provided for in 12 priority countries, identified primarily through the Inter-Agency Standing Committee and the polio programme. In addition a senior coordinator post, that will work closely with the global team, is being established in each of the six Regional Director’s offices. Each Regional Director has a team of senior staff members working on the matter in close collaboration with the global team. The WHO Health Emergencies Programme holds monthly meetings with Heads of WHO country offices in fragile and conflict-affected countries to provide guidance and support, resolve issues and strengthen leadership and senior management commitment in this area. 28. A prevention of and response to sexual exploitation and abuse and sexual harassment learning pathway for all WHO Health Emergencies Programme staff members and focal points was introduced in January 2022. There are ongoing efforts to further mainstream and integrate prevention of and response to sexual exploitation and abuse and sexual harassment in all health cluster coordination platforms; to ensure improved gender balance in WHO Health Emergency Programme operations; and to mitigate the risks of sexual exploitation and abuse and sexual harassment. To strengthen human resource capacities in prevention of and response to sexual exploitation and abuse and sexual harassment to cope with its multiple emergency response operations, WHO is reinforcing its collaboration and partnerships with the standby partner mechanisms to support deployment of experts to high-risk graded emergency operations. STAFF ENGAGEMENT, AWARENESS AND CAPACITY-BUILDING 29. WHO introduced the new United Nations mandatory training on prevention of and response to sexual exploitation and abuse and sexual harassment in October 2021. All staff members must complete the training within three months, and all new personnel working in emergencies must complete it before they can work in or be deployed to the field. By February 2022 the training had been assigned to around 15 400 persons – staff and non-staff – with a global completion rate of 90%. An interim WHO-specific training is available and is being used to brief and train staff members across the Organization. The WHO-specific training has been piloted among 100 personnel across the world, and is due to be launched globally and will be made mandatory for all staff during the second half of 2022. A module on the subject has been introduced for the first time into staff induction briefings in 2021 and will A75/29 10 continue to be a stand-alone session in 2022. Materials are being developed for introduction into pre-deployment training for health emergency responders, country readiness training, Health Cluster Coordinator training, front-line polio worker training and training for Emergency Medical Teams, the Global Outbreak and Alert Response Network and other networks and partners associated with WHO, including the WHO Global Emergency Operations Centres Network, applying lessons-learned and best practices from the United Nations system and the Inter-Agency Standing Committee. In March 2022, WHO assigned to its workforce a new United Nations mandatory training course – United to Respect: Preventing Sexual Harassment and Other Prohibited Conduct. 30. The engagement of personnel for prevention of and response to sexual exploitation and abuse and sexual harassment will intensify throughout 2022. This is part of a #NoExcuse engagement campaign that will ensure that each and every person working for and with WHO knows the zero-tolerance goals related to sexual exploitation and abuse and sexual harassment, knows and acts on their responsibility to report any suspicions, and is aware of the enhanced responsibilities of supervisors and managers. The #NoExcuse campaign increases the awareness of managers concerning their responsibility to create and maintain an environment that prevents sexual exploitation and abuse and sexual harassment and that promotes timely action and response to incidents, including reporting to WHO’s investigational services. WHO vacancy notices and procurement contracts now outline WHO’s position and conditions regarding prevention of and response to sexual exploitation and abuse and sexual harassment. The #NoExcuse campaign is observed by all WHO personnel during WHO’s Goals Week (28 February–4 March) where staff and supervisors discussed performance goals and objectives for the year including those related to the prevention and response to sexual exploitation, abuse and harassment. The week was launched with a leadership letter written by the Director-General and all six Regional Directors to each member of the WHO workforce outlining their expectations related to zero tolerance for sexual exploitation and abuse and sexual harassment and for inaction against it. For the 2022 electronic performance management and development system (ePMDS), all WHO supervisors were required to hold at least one team meeting in which to discuss prevention of and responding to sexual exploitation and abuse and sexual harassment and, with their teams, to select a team goal to be achieved in that area. Staff members will be offered a series of learning, capacity development and engagement activities throughout 2022, and all staff must re-affirm their commitment to relevant policies before being able to submit their ePMDS forms. At the end of the year. supervisors will be required to attest that everyone under their supervision has completed all mandatory training, which currently includes the United Nations mandatory training in prevention of sexual exploitation and abuse, the United Nations training on addressing sexual harassment, as well as WHO’s own agency-specific training on prevention of and response to sexual exploitation and abuse and sexual harassment. 31. Following the introduction of WHO’s Policy on Preventing and Addressing Abusive Conduct on 1 March 2021, the Secretariat implemented a communication campaign to raise the workforce’s awareness of abusive conduct, the support available within the Organization, and the mechanisms through which reports may be made and offenders held accountable. Actions to promote engagement have included Organization-wide information sessions, dissemination of communication and guidance materials, and ongoing training at all levels of the Organization. Special emphasis has been placed on the role of managers and supervisors and the empowerment of all members of the workforce to immediately intervene or to report instances of abusive conduct. Since the policy’s adoption, an estimated 4000 staff members have attended the information sessions and training. 32. The global team on prevention of and response to sexual exploitation and abuse and sexual harassment held briefings and training sessions for more than 8500 staff members between July 2021 and February 2022, reaching personnel across all levels of the Organization, including Heads of WHO country offices and their staff members, incident managers from the African, European, Eastern Mediterranean and the Western Pacific regions, members of the network of country focal points on A75/29 11 prevention of and response to sexual exploitation and abuse and sexual harassment, staff members from technical departments and the United Nations global prevention of sexual exploitation and abuse focal point network. 33. Thus, WHO is reaffirming with all staff and partners that they have not only an obligation to abstain from any behaviour that may constitute sexual exploitation and abuse and sexual harassment, but also an obligation to report any suspected incidents through established reporting processes. Managers, senior managers, Heads of country offices all have an added role to play to create the systems and environment for effective prevention, early detection, safe reporting and support to victims and survivors. ENGAGING STAKEHOLDERS ACROSS THE UNITED NATIONS SYSTEM 34. WHO has taken concrete measures to learn from and align efforts on prevention of and response to sexual exploitation and abuse and sexual harassment with initiatives taken by other organizations in the United Nations system and the Inter-Agency Standing Committee, in order to strengthen significantly the Organization’s inputs into system-wide efforts. WHO has been working with the Special Coordinator on improving the United Nations response to sexual exploitation and abuse; the Office of the Victims’ Rights Advocate; the Inter-Agency Standing Committee; the Office of the Special Representative of the Secretary-General on Sexual Violence in Conflict; and other entities in the United Nations system. 35. Lessons have been drawn from the experiences of partner agencies and concrete priority areas of collaboration have been identified with organizations in the United Nations system (including the International Organization for Migration, UNESCO, UNFPA, UNHCR, UNICEF and the World Food Programme); various nongovernmental organizations and professional associations (including Oxfam and the Fédération Internationale de Football Association) and multilateral and international organizations (including the World Bank, The Global Fund to Fight AIDS, Tuberculosis and Malaria, GAVI – the Vaccine Alliance, and Unitaid). The aim is to ensure WHO’s alignment within the existing framework of United Nations entities and other interagency mechanisms, and to collaborate on current best practices for prevention and response to sexual exploitation, abuse and harassment. Priority bilateral collaborations with partner agencies include a commitment to closer country-level collaboration with UNHCR on risk assessment; with IFRC, UNICEF and more than 50 agencies that make up the Risk Communication and Community Engagement collaborative service on integrating prevention of and response to sexual exploitation and abuse and sexual harassment in their work with communities, including for the COVID-19 vaccine rollout; and with World Vision, which this year assumed the Inter-Agency Standing Committee Championship on Prevention from Sexual Exploitation and Abuse and Sexual Harassment: on (i) defining, standardizing, and operationalizing a survivor-centred approach to prevention work, investigations, and response to sexual exploitation and abuse and sexual harassment violations; (ii) supporting the deployment of Inter-Agency Standing Committee coordinators in prevention of sexual exploitation and abuse in highest risk contexts; and (iii) continuing the process of culture change, ensuring a zero-tolerance approach for inaction. 36. Since July 2021 WHO has intensified its collaboration with other bodies in the United Nations system, for instance in the areas of victim- and survivor-centred approaches and frameworks, risk assessment and management, capacity-building, dealing with sexual exploitation, abuse and harassment in health emergencies, application of the United Nations Protocol on Allegations of Sexual Exploitation and Abuse involving Implementing Partners, and reporting through the Secretary-General’s electronic incident reporting form among others. A75/29 12 37. The findings of the external review of the Inter-Agency Standing Committee’s approach to prevention of and response to sexual exploitation and abuse and sexual harassment, released in November 2021, which examined the body’s past 10 years of work, identified some of the main barriers to inter-agency collaboration. These included: the failure of some entities to adopt a victim- and survivor-centred approach; the length of time it takes, across the United Nations system, to conduct and conclude investigations into sexual exploitation and abuse and sexual harassment; the overengineering of community-based complaint mechanisms, and the lack of confidence in them; and the lack of long- term cultural and attitudinal change to all forms of sexual misconduct. The report and these findings indicate that achieving the desired changes requires a long-term vision, strategy, collaboration, capacity and resources; this includes WHO becoming a strong participant in international efforts to safeguard its programmes and operations against sexual exploitation and abuse. 38. In the first quarter of 2022, the Director-General has reported to the United Nations Secretary-General on progress on prevention of and response to sexual exploitation and abuse and sexual harassment; WHO has completed the implementation of the 2021 Action Plan on prevention of and response to sexual exploitation and abuse and sexual harassment, managed by the Office of the Special Coordinator on improving the United Nations response to sexual exploitation and abuse; and the Secretariat has contributed to the United Nations Secretary-General’s special measures report to the United Nations General Assembly. OVERSIGHT 39. The Secretariat has provided quarterly updates to Member States as requested by the Board in decision EB148(4), together with ad hoc updates and briefings to Member States individually and in groups upon request. 40. Following the establishment of the task team (see paragraph 3) the Director-General invited the Chair of the Independent Oversight and Advisory Committee for the WHO Health Emergencies Programme to establish a subcommittee of its members to consider how the Organization’s current policies and procedures on the prevention of and response to sexual exploitation and abuse and sexual harassment could be improved to achieve best-in-class status and to oversee, guide and monitor the Secretariat’s work in this regard.1 The subcommittee constituted and consulted a reference group of interested Member States to advise on good practices in safeguarding against sexual exploitation, abuse and harassment and held a series of consultations with various external stakeholders and WHO staff members to compare WHO’s policies, procedures, structures and resources with international best-in- class standards. The subcommittee recommends urgent action by the Secretariat in five priority areas: (1) clarifying accountabilities, lines of responsibility and delegation of authority across the three levels of the Organization and strengthen the accountability framework for emergency response and other field operations, including for preventing and responding to sexual exploitation, abuse and harassment; (2) reforming the Organization’s management structure for preventing and responding to sexual exploitation, abuse and harassment, and accelerating the scale-up of organizational capacity to implement a victim/survivor-centred approach to preventing and responding to sexual exploitation, abuse and harassment; (3) investing in preventing and responding to sexual exploitation, abuse and harassment as an essential function; (4) developing and implementing a context-specific, risk-informed, risk-management strategy for preventing and responding to sexual exploitation, abuse and harassment in field operations; and (5) promoting, advocating for and institutionalizing culture change in order to 1 WHO. IOAC sub-committee on the prevention of sexual exploitation, abuse and harassment (PRSEAH). Geneva: World Health Organization; 2021 (https://www.who.int/groups/independent-oversight-and-advisory-committee/sub- committee-on-prseah, accessed 30 March 2022). A75/29 13 strengthen prevention of and response to sexual exploitation, abuse and harassment, including greater gender and racial diversity, improved performance management and a renewed commitment to WHO values. 41. As noted above, progress has been made in the implementing recommendations (2), (3) and (4) of the Independent Oversight Advisory Committee’s subcommittee’s recommendations. Recommendation (1) is being addressed as a matter of priority and recommendation (5) will be addressed in the medium and long term partly by aligning with initiatives underway in human resources and talent management, and initiatives on diversity, equity and inclusion. In addition a new leadership coaching programme will be supported for the area of prevention of and response to sexual exploitation and abuse and sexual harassment, to support female leadership development. 42. As noted in paragraph 7, the Independent Expert Oversight and Advisory Committee will provide oversight of the implementation of the Independent Commission’s recommendations which are now integrated into the WHO Management Response Plan for prevention of and response to sexual exploitation and abuse and sexual harassment. CHALLENGES 43. Tackling sexual exploitation and abuse and sexual harassment is a shared responsibility. WHO has made good progress in strengthening its engagement and participation with other United Nations and humanitarian actors to address the matter in countries. However, to achieve greatest impact, the Secretariat needs to intensify its engagement with and support to governments and authorities in countries where WHO has programmes and operations. This includes the strengthening of gender-based violence referral services so that all victims and survivors, including those affected by sexual exploitation and abuse can safely access the support they need. The role of WHO Member States should be clearly articulated in the proposed three-year WHO strategy on prevention of and response to sexual exploitation and abuse and sexual harassment to be developed in 2022. 44. The Organization has committed core funds for the establishment of institutional capacity for prevention and response, but further funding and institutional capacity are required for safeguarding WHO’s community-facing programmes and response operations. As such, all emergency operations and their respective humanitarian appeals and resourcing mechanisms will have to allocate an agreed percentage of their overall budgets to supporting this area of work. Such investment is needed to implement effective prevention efforts and avert further incidents, and should be applied to other large community-facing programmes, such as the polio eradication programme. 45. Addressing the systemic issues that provide opportunities for sexual exploitation, abuse and sexual harassment to happen within the Organization and transforming the Organization’s culture require long-term and sustained action. There is need to invest in the broader, Organization-wide accountability functions and approaches that promote a respectful workplace. This includes strengthening and stabilizing investigation function capacity, including with dedicated expertise for conducting trauma-informed case investigations into sexual exploitation and abuse and sexual harassment and other forms of abusive conduct that incorporate a victim- and survivor-centred approach, and to report out anonymized data to track progress. 46. As the Organization expands its own capacity to tackle this matter, it relies on delivering results through implementing partners. Therefore, it needs to provide support to partners so that they have the necessary human and technical capacity to effectively implement adequate safeguarding measures. The lack of expertise to fill the major gap in the human resources needed within the Secretariat and across A75/29 14 the United Nations system is already evident. Prevention of and response to sexual exploitation, abuse and harassment is a new area of expertise that draws on many disciplines without a well-defined educational or professional path. Existing pools of experts are limited in size, difficult to access and resource. The Secretariat proposes that efforts are made within WHO and across the United Nations system to professionalize this area of expertise and to contribute to the development of a global pool of expertise, using modern adult-learning approaches, which can support work in countries, programmes and operations. CONCLUSION 47. WHO reaffirms its commitment to zero tolerance for sexual exploitation and abuse and sexual harassment and for inaction against it. Sexual exploitation and abuse of the people served by WHO is a grave failure of the Organization to do no harm and to protect the vulnerable. Sexual harassment and sexual abuse within the Secretariat is a fundamental failure of the Organization’s duty of care to its workforce and a failure to provide a safe and respectful environment in which to serve. WHO is committed to providing a respectful work environment and to promoting and enforcing policies that respect the inherent dignity of all persons, including those whom the Organization serves. WHO has an abiding responsibility to prevent and respond to discrimination, abuse of authority, harassment, including sexual harassment, and sexual exploitation and abuse. ACTION BY THE HEALTH ASSEMBLY 48. The Health Assembly is invited to note the report. = = = SEVENTY-FIFTH WORLD HEALTH ASSEMBLY WHA75.14 Agenda item 21.6 28 May 2022 Global strategy and plan of action on public health, innovation and intellectual property The Seventy-fifth World Health Assembly, Having considered the consolidated report by the Director-General;1 Recalling resolutions WHA61.21 (2008), WHA62.16 (2009), WHA68.18 (2015) and WHA72.8 (2019) and decisions WHA71(9) (2018) and WHA73(11) (2020) on the global strategy and plan of action on public health, innovation and intellectual property that aims to promote new thinking on innovation and access to medicines; Reiterating the essential role that the global strategy and plan of action on public health, innovation and intellectual property plays in directing and coordinating WHO’s policies and programme on this interface, including the WHO–WIPO–WTO trilateral cooperation; Stressing that the relationship, including the balance, between public health, innovation and intellectual property is a critical component of sustainable and resilient health systems, as well as but not limited to the prevention of, preparedness for and response to health emergencies, including the continuing pandemic of coronavirus disease (COVID-19) and future pandemics; Acknowledging the continued value of the principles and elements of work enshrined in the global strategy and plan of action on public health, innovation and intellectual property, which guide and frame the work of WHO on access to medicines and other health products; Reaffirming the goals and objectives of the global strategy and plan of action on public health, innovation and intellectual property, and recognizing the important contribution and prioritization effort made by the overall programme review of the global strategy and plan of action on public health, innovation and intellectual property;2 Renewing the expression of Member States’ shared concern about the pace of implementation of the global strategy and plan of action on public health, innovation and intellectual property by stakeholders as defined in the global strategy,3 which was further hindered by the challenges posed by the COVID-19 pandemic; 1 Document A75/10 Rev.1. 2 Overall programme review of the global strategy and plan of action on public health, innovation and intellectual property. Report of the review panel. November 2017 (https://cdn.who.int/media/docs/default-source/essential- medicines/intellectual-property/gspa/gspa-phi3011rev.pdf?sfvrsn=c66f768b_5, accessed 6 April 2022). 3 Document A61/9, Appendix to Annex 1; see also resolution WHA61.21 (2008), Annex, resolution WHA62.16 (2009) and document A62/16 Add.3. WHA75.14 2 Noting the contribution that several activities within the plan of action on public health, innovation and intellectual property might have in helping to meet targets set in the Sustainable Development Goals, 1. DECIDES to extend the time frame of the plan of action on public health, innovation and intellectual property from 2022 to 2030; 2. URGES Member States: (1) to reinforce the implementation, as appropriate and taking into account national contexts, of the recommendations of the review panel that are addressed to Member States to the extent they are consistent with the global strategy and plan of action on public health, innovation and intellectual property; (2) to identify and share, through informal consultations to be convened by the WHO Secretariat at least every two years, best practices related to the implementation of actions within the global strategy and plan of action on public health, innovation and intellectual property; 3. REITERATES to the Director-General the importance of allocating the necessary resources to implement the recommendations of the review panel of the overall programme review of the global strategy and plan of action on public health, innovation and intellectual property1 addressed to the Secretariat as prioritized by the review panel, to the extent they are consistent with the global strategy and plan of action on public health, innovation and intellectual property; 4. REQUESTS the Director-General: (1) to continue to provide technical assistance and share knowledge that could enable countries to implement actions consistent with the global strategy and plan of action on public health, innovation and intellectual property; (2) to promote collaboration and coordination within and among countries and with relevant stakeholders, for the implementation of actions consistent with the global strategy and plan of action on public health, innovation and intellectual property; (3) to identify potential synergies in and challenges to ongoing work within the Secretariat for the implementation of actions consistent with the global strategy and plan of action on public health, innovation and intellectual property; (4) to conduct, in 2023, a review of the indicators included in the overall programme review of the global strategy and plan of action on public health, innovation and intellectual property1 in consultation with Member States,2 and to develop proposed revisions to align indicators with the new term of validity of the plan of action; 1 Overall programme review of the global strategy and plan of action on public health, innovation and intellectual property. Report of the review panel. November 2017 (https://cdn.who.int/media/docs/default-source/essential- medicines/intellectual-property/gspa/gspa-phi3011rev.pdf?sfvrsn=c66f768b_5, accessed 6 April 2022). 2 And, where applicable, regional economic integration organizations. WHA75.14 3 (5) to report to the Health Assembly in 2024, 2026 and 2028 on the implementation of the global strategy and plan of action on public health, innovation and intellectual property and the present resolution; 5. ENCOURAGES non-State actors in official relations with WHO to engage with countries in the implementation of actions consistent with the global strategy and plan of action on public health, innovation and intellectual property. Eighth plenary meeting, 28 May 2022 A75/VR/8 = = = SEVENTY-FIFTH WORLD HEALTH ASSEMBLY WHA75(19) Agenda item 27.3 28 May 2022 Traditional medicine The Seventy-fifth World Health Assembly, having considered the report by the Director-General,1 Decided to request the Director-General to submit a final report on progress made in the implementation of resolution WHA67.18 (2014) to the Seventy-sixth World Health Assembly in 2023, through the Executive Board at its 152nd session, by means of a consolidated document that responds also to the request made in decision WHA73(15) (2020) in respect of global strategies or action plans that are scheduled to expire within one year. Eighth plenary meeting, 28 May 2022 A75/VR/8 = = = 1 Document A75/42. SEVENTY-FIFTH WORLD HEALTH ASSEMBLY WHA75(20) Agenda item 27.4 28 May 2022 Public health dimension of the world drug problem The Seventy-fifth World Health Assembly, having considered the report by the Director-General,1 Decided to request the Director-General to continue to report to the Health Assembly every two years until 2030 on WHO’s activities to address the public health dimensions of the world drug problem and progress made in the implementation of decision WHA70(18) (2017). Eighth plenary meeting, 28 May 2022 A75/VR/8 = = = 1 Document A75/43. MINISTRY OF HEALTH REPUBLIC OF MALDIVES 1 South-East Asia Regional One Voice (ROV): Delivered by Maldives 75th World Health Assembly (WHA 75) Agenda Item 27.4: Public health dimension of the world drug problem Thank you, Chair. Maldives delivers this statement on behalf of SEAR Member States. SEAR appreciate the WHO’s efforts on strengthening the prevention and treatment of drug use disorders. We note the report by the Director General and support the decision. Public health problems related to substance use, substance use disorders and related health conditions is to a large extent preventable, however, estimated 583000 deaths are either directly or indirectly related to drug use and about 275 million people use psychoactive drugs, with an estimated 11% rise. SEAR acknowledges the adoption of recommendations by the WHO Expert Committee on Drug dependence by the Commission on Narcotic Drugs, the Stop Overdose Safety (SOS) initiative and the newly established inter-agency working group on prevention of drug use and treatment of drug use disorders. Chair, The growing substance production and trading industry poses a global challenge with the increased availability and usage of a broader range of illicit drugs. The expansion of domestic drug markets has placed a huge burden on substance use treatment and increased pressure to provide adequate and effective treatment in addition to added burden on related health services. SEAR is concerned by the very low access of medication for moderate and severe pain and recognize the need for access to pain relief must be balanced with concerns about the harm arising from the misuse and balanced national policies are crucial. MINISTRY OF HEALTH REPUBLIC OF MALDIVES 2 While some SEAR countries have made progress in amending National Essential Medicine list to include opioids and other psychotropic drugs to improve access there is disparity in access within the countries, in addition to oppressive laws, punitive actions for stock management errors, and fear and stigma of opioid use creating barriers to access. Chair, COVID-19 pandemic has had a significant impact on provision of health services, especially for persons with substance use disorders. SEAR recommends addressing substance use disorders within the context of primary care aimed at promoting and supporting prevention, early identification and effective management; improved access and availability of opioids at all levels of health care; reducing the burden of drug-related infectious diseases; prevention of the harm associated with drug use; effective monitoring of the health consequences of drug use and promoting a multi-sectoral, whole of government, whole of society multidisciplinary and comprehensive approach in addressing the problem. Chair, SEAR request WHO to intensify its effort in limiting common barriers for integrated substance-use care; address public health issues of substance-use within the context of universal health coverage; Invest in developing human resources, implement and integrate evidenced based interventions for substance use disorder at health care facilities, assist in developing information management systems, promote community management and family-based care, address substance-use disorders in pregnancy and support further action at legislative and policy level for both prevention, treatment of substance use disorders Thank you, Chair. EXECUTIVE BOARD EB151(2) 1151st session 30 May 2022 Agenda item 5 Standing Committee on Health Emergency Prevention, Preparedness and Response The Executive Board, having considered the report on the Standing Committee on Health Emergency (Pandemic) Prevention, Preparedness and Response;1 and taking into account decision EB150(6) (2022), including the request to the Director-General to report on the functioning and impact of the Standing Committee and submit the results and proposed recommendations based thereon for the consideration of the Executive Board at its 156th session in January 2025, Decided: (1) in accordance with Rule 18 of the Rules of Procedure of the Executive Board, to establish a Standing Committee on Health Emergency Prevention, Preparedness and Response; (2) to approve the terms of reference set out in the Annex to this decision; and (3) that the Standing Committee on Health Emergency Prevention, Preparedness and Response will hold its first meeting after each WHO region has nominated its members and the Executive Board formally appoints the members through a silence procedure, ideally before the end of October 2022. 1 Document EB151/3. EB151(2) 2 ANNEX TERMS OF REFERENCE OF THE STANDING COMMITTEE ON HEALTH EMERGENCY PREVENTION, PREPAREDNESS AND RESPONSE Composition and attendance 1. The Standing Committee on Health Emergency Prevention, Preparedness and Response (“the Standing Committee”) shall be composed of 14 members, two from each region, selected from among Executive Board members, as well as the Chair and a Vice-Chair of the Board, ex officio, in line with the principles set out in Rule 18 of the Rules of Procedure of the Executive Board reflecting a balanced representation of developed and developing countries. Members of the Standing Committee shall serve for two years. 2. There shall be two office-bearers: a Chair and a Vice-Chair, who shall be appointed among the Committee members, in line with the principles set out in Rule 18 of the Rules of Procedure of the Executive Board, and shall serve for a one-year term. 3. The Chair and the Vice-Chair, in collective consultation with the Director-General, may invite observers1 to attend a meeting of the Standing Committee without the right to vote if they consider that this would enhance the work of the Standing Committee on a specific item or items on the agenda of the meeting. Furthermore, the Chair and the Vice-Chair, in consultation with the Director-General, may invite experts to attend a meeting of the Standing Committee to provide advice, as appropriate. Members of the Standing Committee can also propose the invitation of relevant experts. 4. Member States in whose territory an event arises shall be invited to present their views to the Standing Committee. Functions 5. The Standing Committee shall act as follows: (a) In the event a public health emergency of international concern (PHEIC) is determined pursuant to the International Health Regulations (2005): Consider information provided by the Director-General about the event that has been determined to constitute a PHEIC as well as information and needs expressed by the Member State in whose territory an event arises and, as appropriate, provide guidance to the Executive Board and advice to the Director-General, through the Executive Board, including through a special session as needed, on matters regarding health emergency prevention, preparedness and response, and immediate capacities of the WHO Health Emergencies Programme. 1 For the purposes of attending and addressing the Standing Committee reference to “observers” is understood as referring to the Holy See; Palestine; Gavi, the Vaccine Alliance; the Order of Malta; the International Committee of the Red Cross; the International Federation of Red Cross and Red Crescent Societies; the Inter-Parliamentary Union; the Global Fund to Fight AIDS, Tuberculosis and Malaria; the United Nations and other intergovernmental organizations with which WHO has established effective relations under Article 70 of the Constitution; the European Union; and any other body so authorized for these purposes by the Executive Board. Annex EB151(2) 3 (b) Outside of the cases where a PHEIC is determined pursuant to the International Health Regulations (2005): Review, provide guidance and, as appropriate, make recommendations to the Executive Board regarding the strengthening and oversight of the WHO Health Emergencies Programme and for effective health emergency prevention, preparedness and response. 6. In performing its functions, the Standing Committee shall take into account the work of other relevant WHO instruments and bodies, as appropriate. The Standing Committee shall work in a manner respectful of and complementary to the technical scientific advice provided by the Emergency Committee in accordance with the International Health Regulations (2005). Conduct of sessions 7. The Standing Committee shall meet at least twice annually for the conduct of its regular work. Decisions on the format1 of the meeting shall be made by the Chair and Vice-Chair of the Standing Committee, in consultation with the Director-General. 8. In the event a PHEIC is determined pursuant to the International Health Regulations (2005), the Director-General shall convene an extraordinary meeting of the Standing Committee as soon as reasonably practicable, and ideally within 24 hours following the determination of the PHEIC. 9. The Executive Board may decide to convene extraordinary meetings of the Standing Committee in order to deal with urgent matters that fall within its terms of reference and are deemed necessary to be considered between its regular meetings. 10. The Standing Committee shall conduct its business on the basis of consensus and transparency. The Standing Committee will provide a report of each of its meetings to the Executive Board. In the event of inability to reach consensus, the difference in views shall be reported to the Board. 11. The meetings of the Standing Committee shall be open for all Member States. Second meeting, 30 May 2022 EB151/SR/2 = = = 1 In person, virtual or hybrid.

REGIONAL COMMITTEE Provisional Agenda item 10.1 Seventy-fifth Session SEA/RC75/15 Add. 1 Paro, Bhutan 5–9 September 2022 18 August 2022 Key issues arising out of the Seventy-fifth World Health Assembly and the 150th and 151st sessions of the WHO Executive Board: Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 The Seventy-fourth session of the WHO Regional Committee for South-East Asia adopted Decision SEA/RC74(4)2 that requested the Regional Director to undertake a consultative process to develop an integrated Regional Action Plan (RAP) on viral hepatitis, HIV and STIs in South-East Asia, 2022–2026, in alignment with the SDGs and GHSS, for the consideration of and endorsement by the Regional Committee at its Seventy-fifth Session in 2022. Following a detailed consultative process, the integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 has been finalized and is attached to this Working Paper as Addendum. The ‘Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026’ is now submitted to the Seventy-fifth Session of the WHO Regional Committee for South-East Asia for its consideration and adoption. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 The Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 (I-RAP) shares a common vision to end the epidemics of viral hepatitis, HIV and STI in the South-East (SE) Asia Region by 2030. The five strategic directions oriented around service delivery, health systems, strategic information, community empowerment and innovations provide the overall guiding framework for country actions to implement the strategies. The integrated approach will help increase quality and efficiency and leverage the full power of primary health care, universal health coverage (UHC) and health systems for impact. It will promote equity and innovation, and advance people-centred and community-driven approaches. The I-RAP provides a comprehensive regional framework of shared and disease-specific actions to guide countries and partners. Individual countries can adapt these actions in relation to local epidemiological and health system contexts, upholding fundamental human rights, including the cross-cutting principle of equality and non-discrimination in the availability, accessibility, acceptability and quality of health services, products, approaches and interventions. The optimal selection of actions and service delivery models should be aligned with broader national strategies within a UHC framework and be responsive to the needs of individuals and local communities without any stigma or discrimination. 9 789290 209683 Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 ii ISBN: 9789290209683 Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 © World Health Organization 2022 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). 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The responsibility for the interpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arising from its use. Contents Foreword v Acknowledgements vii Acronyms and Abbreviations viii Glossary x Executive summary xi 1. Global and regional integrated elimination agenda 1 1.1 Integrated global action to end epidemics 2 1.2 Vision, goals, strategic directions and targets 3 1.3 Regional situation and response in SE Asia 9 1.4 An Integrated Regional Action Plan to accelerate response towards elimination in the SE Asia Region 15 1.5 The Integrated Regional Action Plan development process 18 2. Shared actions for a people-centred tailored response 21 2.1 Priority areas addressed through the I-RAP 22 2.2 Key targets across viral hepatitis, HIV and STI 23 2.3 Strategic Direction 1: deliver high-quality, evidence-based, people-centred services 25 2.4 Strategic Direction 2: optimize systems, sectors and partnerships for impact 32 2.5 Strategic Direction 3: generate and use data to drive decisions for action 36 2.6 Strategic Direction 4: engage empowered communities and civil society 37 2.7 Strategic Direction 5: foster innovations for impact 38 2.8 HIV, syphilis and hepatitis B triple elimination 39 3. Viral hepatitis 41 3.1 Key areas for urgent attention towards the regional elimination goal 41 3.2 Core regional targets and additional targets for 2025 43 3.3 Strategic Direction 1: deliver high-quality, evidence-based, people-centred services 44 3.4 Strategic Direction 2: optimize systems, sectors and partnerships for impact 48 3.5 Strategic Direction 3: generate and use data to drive decisions for action 49 3.6 Strategic Direction 5: foster innovations for impact 50 4. HIV 51 4.1 Key areas for urgent attention towards the regional elimination goal 51 4.2 Strategic Direction 1: deliver high-quality, evidence-based people-centred services 54 Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 iv 4.3 Strategic Direction 2: optimize systems, sectors and partnerships for impact 57 4.4 Strategic Direction 3: generate and use data to drive decisions for action 59 4.5 Strategic Direction 5: foster innovations for impact 60 5. Sexually transmitted infections 62 5.1 Key shifts required to strengthen STI control in the Region 62 5.2 STI targets 63 5.3 Core Regional targets and additional targets for 2025 64 5.4 Strategic Direction 1: deliver people-centred evidence-based services 64 5.5 Strategic Direction 2: optimize systems, sectors and partnerships 68 5.6 Strategic Direction 3: generate and use data to drive decisions for action 70 5.7 Strategic Direction 5: foster innovations for impact 71 6. Implementing the Integrated Regional Action Plan 72 6.1 Political advocacy and commitment 72 6.2 Governance supporting the integrated model of service delivery 72 6.3 Active participation of communities of key populations in delivery of services 75 6.4 Strategic information – integrated data systems 75 6.5 Optimization of technical resources, training and capacity enhancement 76 6.6 Integration and strengthening of laboratory services 76 6.7 Procurement and logistics 76 6.8 Innovations and how they help in strengthening the regional response 76 6.9 Risk mitigation strategies for implementation of the Integrated Regional Action Plan 77 7. Monitoring and evaluation 78 8. WHO Actions to keep the Integrated Regional Action Plan on track 80 9. Financing of the Regional Action Plan 83 9.1 HIV 83 9.2 Viral hepatitis 86 9.3 STI 88 References 91 Annexures Annex 1: Measurement framework 93 Annex 2 – Summary of required impact and process targets for country validation of EMTCT of HIV, syphilis and HBV (25) 102 Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 v Foreword Viral hepatitis, HIV and STI are major public health problems globally and in the WHO South-East (SE) Asia Region. The WHO SE Asia Region accounts for 20% of the global burden of hepatitis B and C and 10% of the global burden of HIV. It also accounts for 16% of the burden of the four curable STI. Between 2010 and 2020, the Region achieved a 46% reduction in new HIV infections, a 64% decline in HIV-related deaths, and tripling of the coverage of antiretroviral therapy. Nine countries have achieved more than 90% coverage of the third dose of hepatitis B vaccine and four countries have reached the hepatitis B control target of less than 1% seroprevalence of HBsAg among children 5 years of age. The proportion of new cases of four curable STI has declined from a third of the total global estimate in the 1990s to 26% in 2019. Despite this progress, the Region must accelerate action to end the epidemics of viral hepatitis, HIV and STI by 2030, leveraging the full power of universal health coverage (UHC), primary health care (PHC), and meaningful engagement of communities. To do that, the WHO Regional Office for South-East Asia has developed this Integrated Regional Action Plan (I-RAP) on viral hepatitis, HIV and STI for the period 2022–2026, which is aligned with the Sustainable Development Goals, the WHO Global Health Sector Strategies on HIV, viral hepatitis and STI (2022–2030), the Global AIDS Strategy 2021 –2026, and the Regional Flagship Priorities on UHC and achieving the elimination of select diseases. The I-RAP was finalized following wideranging consultations with an array of stakeholders, including national programme managers, infected and affected communities, at-risk and vulnerable populations, civil society, nongovernmental organizations, and partner UN agencies. It strives to increase quality and efficiency and leverage the full power of PHC, UHC and health systems for impact. It promotes equity and innovation, and advances people-centred and community-driven approaches. It draws on the many lessons learnt from the HIV, hepatitis and STI prevention and treatment responses, accelerating a synergistic and integrated public health approach along the entire continuum of care. The I-RAP provides a comprehensive Regional Framework covering 23 shared and 37 disease-specific actions to guide countries and partners in their efforts to end the epidemics. Individual countries are encouraged to select, set priorities for, and adapt these actions based on local epidemiological and health system contexts. In addition, the I-RAP identifies seven key actions that WHO must take to support implementation. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 vi Together, we must sustain and accelerate progress, harnessing the full impact of innovation, and strengthening political and financial commitments. WHO is committed to supporting all stakeholders and partners to leverage this I-RAP to end the epidemics of viral hepatitis, HIV and STI by 2030, and to achieve a South-East Asia Region that is healthier, more equitable and health-secure, and provides sustainable health care. Dr Poonam Khetrapal Singh Regional Director WHO South-East Asia Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 vii Acknowledgements The South-East Asia Regional Office of the World Health Organization would like to acknowledge the contributions made by all experts and reviewers in the development of this Integrated Regional Action Plan for viral hepatitis, HIV and STI for South-East Asia for the period 2022 to 2026. The document has been developed under the overall guidance of Dr Suman Rijal, Director, Department of Communicable Diseases at the Regional Office. Guidance provided by Dr JVR Prasada Rao, Special Adviser to the Regional Director and Chair of the Technical Working Group (TWG) on the Regional Action Plan, contributed significantly towards shaping the final publication. Comments and inputs provided by members of the TWG (Dr Anoop Bastola, Dr Khin Pyone Ki, Mr Midnight Poonkasetwattana, Dr Nittaya Phanuphak, Dr Nurhalina Afriana, Dr Rachel Baggaley, Dr Rakesh Aggarwal, Dr Richard Steen, Dr Shiv Kumar Sarin and Dr Yanri Wijayanti Subronto) throughout the development process are duly acknowledged. We also express our thanks to all members of the Strategic and Technical Advisory Group (STAG) on hepatitis (Dr Amit Goel, Dr Anchalee Avihingsanon, Dr David Handojo Muljono, Mr Giten Khwairakpam, Ms Jennifer Johnston, Mr K.C. Prawchan, Dr Mamun Al Mahtab, Dr Thilanga Ruwanpathirana) for their contribution. Inputs provided by communities of infected and affected populations, representatives of various regional- and country-level civil society organizations, networks and NGOs are also hereby acknowledged. The support provided by the team at WHO headquarters, Geneva – led by Dr Doherty Meg, Director, HIV hepatitis and STI, and Dr Daniel Low Beer, Unit Head for Strategic Information at HQ – were of utmost importance in arriving at the 2025 regional targets for these diseases. The Regional Office also acknowledges the valuable contributions by Dr Nick Walsh of the NCCTRC, Darwin and Monash University, Melbourne, Australia. The contributions by the national programme managers from Member States, WHO country office focal points for HIV hepatitis and STI, the UNAIDS regional support team for Asia and the Pacific, the Clinton Health Access Initiative, and colleagues from the UNICEF Regional Office for South Asia and the World Bank’s South Asia Office significantly aided the finalization of disease-specific actions. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 viii Acronyms and Abbreviations AMR antimicrobial resistance ANC antenatal care ART antiretroviral therapy BD birth dose CBO community-based organization CHW community health worker CLM community-led monitoring CSO civil society organization EMTCT elimination of mother-to-child transmission GHSS Global Health Sector Strategies HAV hepatitis A virus HBIg hepatitis B immunoglobulin HBsAg hepatitis B surface antigen HBV hepatitis B virus HCV hepatitis C virus HepB-BD birth dose of hepatitis B vaccine HepB3 third dose of hepatitis B vaccine HEV hepatitis E virus HIV human immunodeficiency virus HPV human papillomavirus I-RAP Integrated Regional Action Plan LDSS low dead-space syringe M&E monitoring and evaluation MSM men who have sex with men MTCT mother-to-child transmission NCD noncommunicable disease NGO nongovernmental organization NSP national strategic plan OST opioid substitution therapy PEP post-exposure prophylaxis PHC primary health care PID pelvic inflammatory disease PLHIV people living with HIV Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 ix PMTCT prevention of mother-to-child transmission PrEP pre-exposure prophylaxis PWID people who inject drugs PWUD persons who use drugs RAP Regional Action Plan RDT rapid diagnostic test SDG Sustainable Development Goal SE South-East STI sexually transmitted infections SW sex worker TB tuberculosis TWG technical working group UHC universal health coverage UNAIDS Joint United Nations Programme on HIV/AIDS UNDP United Nations Development Programme UNICEF United Nations Children’s Fund VPD vaccine preventable disease WHO World Health Organization WUENIC WHO/UNICEF Estimates of National Immunization Coverage Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 x Glossary Affected populations Those members of the community living with the particular infection or disease Community-based organization A public or private non-profit organization that is representative of a community or significant segments of a community and provides educational or related health services to individuals in the community Community health worker (CHW) CHWs are health-care providers who live in the community they serve. They receive lower levels of formal education and training than professional health-care workers such as nurses and doctors. Community-led monitoring (CLM) Community-led or community-based monitoring refers to service users assessing the effectiveness, quality, accessibility and impact of health programmes and services which they receive. Disability Disability is an umbrella term for impairments of bodily function or structure, activity limitations or participation restrictions. This can be physical, intellectual or psychological. Integration In the context of this action plan, integration refers to the combining of health interventions and health programmes to provide people-centred care, regardless of the disease category experienced by the individual. Key populations Key populations are defined groups who, due to specific higher-risk behaviour, are at increased risk of HIV, irrespective of the epidemic type or local context. Also, they often have legal and social issues related to their behaviour that increase their vulnerability to viral hepatitis, HIV or STI. Social contracting The process by which government resources are used to fund entities which are not part of government (herein called civil society organizations) to provide health services which the government has a responsibility to provide, to assure the health of its citizenry. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 xi Executive summary Global action for elimination of viral hepatitis, HIV and sexually transmitted infections (STI) as public health problems began in 2016 when the World Health Assembly agreed to achieve this by 2030. Progress has been mixed to date, with advances in the elimination of mother-to-child transmission (MTCT) of HIV and syphilis, less in overall diagnosis and treatment for hepatitis B and C, and limited progress in addressing these diseases among key populations. The COVID-19 pandemic has further impacted progress in the years following its declaration as a global pandemic in March 2020, through disruption to health systems and service delivery. With a population of 2 billion people, South-East (SE) Asia accounts for a major proportion of infections, sequelae and deaths from these three major communicable diseases. For example, 20% of global deaths from viral hepatitis occur in SE Asia. Specific to this Region is the disproportionate burden of these infectious and other communicable diseases among key populations. Indeed, both HIV and hepatitis C transmission are ostensibly driven by higher incidence among the highest risk populations in the Region, with more than 90% of new HIV infections occurring among key populations and their partners. Since 2016 World Health Assembly endorsement of the global strategies for HIV, viral hepatitis and STI, the Region has initiated action plans to provide operational guidance for countries to achieve elimination through the Regional Action Plan for Viral Hepatitis in South-East Asia (2016–2021), the Regional Action Plan for HIV in South-East Asia (2017–2021) and additional regional work on STI. Nevertheless, action to address these major communicable diseases has been heterogeneous, with mixed progress within and between countries. In addition, the goal of elimination is off track, compounded by the disruptive nature of the COVID-19 pandemic. The WHO Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 (I-RAP) brings together common strategies, actions and specific targets across health systems to promote synergies in the effective prevention, diagnosis and treatment of these major communicable diseases in a patient-centred approach. Apart from focused interventions among groups which are more vulnerable and disproportionately affected, the Integrated Action Plan actively promotes service delivery at the primary health-care level under universal health coverage (UHC). The I-RAP is aligned with the Sustainable Development Goals (SDGs), WHO Global Health Sector strategies (GHSS) on HIV, viral hepatitis and STI (2022–2030), Global AIDS Strategy 2021–2026 and is synergized with the regional flagship priorities on universal health coverage (UHC) and elimination of diseases. The I-RAP has set several priority areas of specific and immediate action required in the Region. These are: (i) a focus on populations that are most affected by and at risk of viral hepatitis, HIV and STI; (ii) a reduction in incidence of all three diseases through preventing transmission; (iii) scaling up substantially, access to testing and treatment; (iv) the elimination of MTCT of HIV and syphilis and movement towards triple elimination; (v) the need to develop effective and inclusive governance structures; (vi) the critical requirement for adequate and sustained financing for the integrated programme; (vii) the need to Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 xii further build capacity in the health workforce; (viii) the importance of empowering communities and community health workers; and (ix) advocating for an environment where innovations are fostered and new technologies operationalized to optimize delivery of effective interventions. Shared actions for a people-centred, tailored response include all of the recommended effective interventions and service delivery models across viral hepatitis, HIV and STI under a UHC and primary health-care framework. Health systems are encouraged to implement these irrespective of the targeted disease, given the commonalities and synergies these actions represent, including and importantly for key and vulnerable populations. Areas of implementation include primary prevention in sexual and reproductive health, harm reduction, integrated testing and treatment, addressing stigma and discrimination, strengthening national inter-programmatic linkages, the use of technologies, decentralization, key components necessary for innovation and sustained response and accelerating legal and regulatory policy reform. Community-led monitoring is a key component of necessary actions across all these major communicable diseases to promote engagement of the affected populations and their communities. The I-RAP provides for full engagement with communities and civil society to foster leadership and empower those most vulnerable. Triple elimination of MTCT of HIV, syphilis and hepatitis B is a specific focus area of the I-RAP. Indeed, it is an example of operationalized integration in the delivery of services using a people-centred approach. This includes strengthening linkages to maternal and child health programmes to extend the reach and penetration of effective interventions for HIV, syphilis and hepatitis B prevention, diagnosis and treatment among pregnant women and the newborn. The I-RAP outlines key actions necessary to address the heterogeneity of hepatitis responses across the Region, with specific focus on key populations. Key areas of action include: increasing timely birth dose of hepatitis B vaccine to 70% of live births by 2025, thereby reducing hepatitis B incidence; markedly reducing mortality from hepatitis B and C through scaling up access to testing and effective treatment; and markedly increasing combination harm reduction interventions for people who inject drugs (PWID) and persons who use drugs (PWUD). In addition, the I-RAP calls for special measures to optimize outcomes for liver disease including the management of cirrhosis and an early diagnosis and treatment for hepatocellular carcinoma (liver cancer) through strengthening linkages to cancer screening programmes and services. The Action Plan builds on earlier efforts to address HIV in the Region but calls for urgent attention towards the regional elimination goal. This includes a specific focus on new infections among key populations, renewed efforts to address transmission among youth, continued efforts to address stigma and discrimination including through policy reform, and promoting community-led service delivery as an important adjunct to facilitate access to these populations. The targets of the I-RAP are aligned with other initiatives including the 95-95-95 HIV target for the Region by 2025. The Plan calls for continued efforts to promote addressing the syndemics of HIV–TB, being a leading cause of death among people living with HIV in the Region, and to reduce the proportion of diagnosis made of HIV with advanced disease. Specific interventions include comprehensive HIV prevention, an expansion of self-testing and point-of-care testing in all contexts and rapid initiation of antiretroviral therapy with adherence support to optimize clinical outcomes and minimize resistance. The STI chapter outlines the key challenges and gaps across the Region. SE Asia has not previously had a separate STI action plan, so the areas for implementation of priority action are directed at promoting Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 xiii enhanced health sector actions to address the expanding epidemic of STI. It is recognized that there is variability in the prevalence and impact of STI across countries of the Region and heterogeneity in access to appropriate diagnostic and treatment services. The Action Plan recognizes successes in the Region and seeks to leverage these within and between countries. This includes the development of flexible toolkit- proven interventions for countries at different stages of STI control. A key gap is limited data across most countries, and the I-RAP calls for increasing support in STI surveillance including routine reporting and prevalence monitoring in specific populations including pregnant women and key populations, and the monitoring of drug resistance to inform effective case management. A specific difference regarding STI is that of reinfection, and the need for treatment services to promote adherence to prevention to consolidate gains made through early diagnosis and treatment. WHO’s recommended prevention, diagnosis and treatment interventions are not effective unless appropriately implemented in an equitable and timely manner. The I-RAP emphasises the critical importance of political commitment in effective implementation of the Plan, which at the national level means country ownership of the nature and extent of the impact of these major communicable diseases. The Action Plan attempts to bridge the gap between previous regional action and the 2030 SDGs. To provide health system integration, the governance of the response should also be strengthened and integrated at the national, provincial and local levels, which may vary depending on the size of the country. Effective implementation calls for the active participation of key populations including through social contracting. Strategic information and data systems also need to be integrated in time, leveraging existing HIV and integrated surveillance systems with those of other disease categories. This includes identifying common metrics and indicators, and strengthening data collection and analysis at the subnational level. The strengthening of laboratory services across the major disease categories will also promote integrated data systems. The COVID-19 pandemic has illustrated that risks to progress do exist and can heavily impact action to achieve elimination. The Action Plan seeks to build on some of the lessons learned during the COVID-19 pandemic including that of the utilization of technology to deliver health services, including telemedicine. Nevertheless, risk mitigation strategies are critical for the achievement of the goals of the Plan. These include strategies to foresee and manage potential lack of political support, potential turf issues in integrating action, the withdrawal of international funding, limited progress in policy reform and natural or public health emergencies. At both the regional and national levels, WHO will closely monitor progress across this plan and commits to advocate for and provide technical support to Member States’ national programmes. WHO will support the development and rollout of evidence-based normative guidance and other relevant tools for programmes, and engage partners at the highest level to ensure that all efforts are coalesced around the objectives of this plan. Finally, the Regional Office will support the development and adaptation of the tools required for monitoring progress and ultimately achieving the validation of elimination of viral hepatitis, HIV and STI in SE Asia.

Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 1 1. Global and regional integrated elimination agenda The world has made substantial progress on the elimination goal for viral hepatitis, human immunodeficiency virus (HIV) and some sexually transmitted infections (STI) as public health threats by 2030 following the global agreement through a resolution at the Seventy-fourth World Health Assembly in 2016. The global HIV epidemic has now been transformed with the focused prevention interventions and large-scale expansion of antiretroviral therapy (ART), reducing global HIV-related deaths to their lowest since 1994. Global hepatitis birth dose (hep B-BD) coverage has expanded greatly and the number of people receiving treatment for chronic hepatitis C virus infection has increased almost tenfold from 2015, reducing hepatitis C-related mortality (1). Several countries and regions have now embraced the triple elimination agenda for eliminating mother-to-child transmission (MTCT) of HIV, syphilis and hepatitis B. The achievements to date, both global and in the WHO South-East (SE) Asia Region, have demonstrated that strong leadership, coupled with innovative technologies and practices, financial investment and community engagement can reduce disease transmission, improve treatment outcomes and save lives. The COVID-19 pandemic interrupted progress during the period starting 2020, and a refocus is necessary to bridge the gap and consolidate the gains achieved so far. Strategic and innovative shifts are needed to protect the progress to date and to bring the Region closer to the goal of ending the epidemics of AIDS, viral hepatitis and STI as public health threats, consistent with the Global Health Sector Strategies (GHSS) goal. Acknowledging the commonalities, differences and potential synergies across these disease areas, the new WHO GHSS 2022–2030 on HIV, viral hepatitis and STI has brought together these three programmes under a common framework, embedded in universal health coverage (UHC) and actioned through a primary health care (PHC) approach. The seventy-fifth World Health Assembly noted with appreciation the three interlinked Global health sector strategies (GHSS) respectively on HIV, viral hepatitis and sexually transmitted infections for the period 2022-2030. These strategies provide broad guidance for this Integrated Regional Action Plan (I-RAP). The 2022–2026 WHO Integrated Regional Action Plan (I-RAP) for SE Asia provides an operational framework for the Region aligned with the global strategies to implement key actions and combine shared and disease-specific approaches. Those infected and affected are placed at the centre of an integrated health sector response including time-bound actions for shared and individual programmes within a UHC framework to achieve elimination. Reflecting the complex interaction of health issues associated with viral hepatitis, HIV and STI, this I-RAP is aligned with other global and regional health strategies and plans that address a wide range of related diseases and health concerns. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 2 1.1 Integrated global action to end epidemics Globally, viral hepatitis, HIV and STI collectively cause 2.3 million deaths and 1.2 million cases of cancer each year,1 and continue to impose a major public health burden worldwide. More than one million people are newly infected with STI each day, and 4.5 million with HIV, hepatitis B and hepatitis C combined, each year. Although progress has been made in all three disease areas, the global response is off-track and most global health targets for 2020 were missed. The multiple epidemics of STI continue to cause a significant disease burden and the global response has lagged severely, resulting from a lack of visibility, funding and implementation support. The full benefits of available tools and technologies are not being realized, many populations are left behind and structural, systemic and financial barriers to accelerating progress persist. The COVID-19 pandemic has further hampered progress and accelerated action is needed to end these epidemics. Building on the achievements and lessons learnt from the 2016–2021 GHSS (2-4), the new GHSS (2022– 2030) on HIV, viral hepatitis and STI guides the health sector in implementing strategically focused responses to achieve the goals of ending AIDS, viral hepatitis B and C and STI by 2030. The strategies recommend shared and disease-specific country actions until 2030, supported by actions by the World Health Organization (WHO) and partners. Implementation is grounded in delivery through the PHC system and the utilization of existing forms of care including for TB, HIV and other medical conditions under the context of UHC. The 2022–2030 strategies underline the critical role of the health sector in ending these epidemics, acknowledging that a multisectoral “health in all policies” approach is required to remove structural and systemic barriers to accelerating progress (5). The strategies call for a more precise focus to reach the people most affected and at risk for each disease and to address inequities. They promote synergies under a UHC umbrella and primary health-care framework and contribute to achieving the goals of the 2030 Agenda for Sustainable Development. 1.1.1 Structure of this document The integrated Regional Action Plan (I-RAP) for viral hepatitis, HIV and STI for 2022–2026 in SE Asia is a single document that includes both shared and disease-specific content. Following this chapter, the document is organized as follows (Fig. 1): ¤ Chapter 2 provides details on the shared actions that are common across viral hepatitis, HIV and STI and are necessary for a people-centred tailored response in SE Asia. These include the concrete example of triple elimination – the integrated elimination of MTCT of HIV, syphilis and hepatitis B. ¤ Chapters 3, 4 and 5 define the disease-specific actions required across viral hepatitis, HIV and STI, respectively to deliver the coverage targets required to reach the impact targets for the three disease areas by 2025 under a UHC and PHC framework. 1 Including hepatocellular carcinoma caused by hepatitis B and C, cervical cancer caused by human papillomavirus and other types of cancers caused by viral hepatitis and human papillomavirus. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 3 ¤ Chapter 6 details the key principles for implementation of this I-RAP across 9 key domains. ¤ Chapter 7 provides the monitoring and evaluation (M&E) framework for the I-RAP aligned with the global framework and existing WHO validation guidance for monitoring and measuring progress towards, and validation of, the elimination of these communicable diseases. ¤ Chapter 8 provides WHO actions to support Member States in maintaining progress towards elimination through the full implementation of this I-RAP. ¤ Chapter 9 provides an estimate of financial resources required to support the I-RAP from 2022 to 2026 in the SE Asia Region. ¤ The annexures provide a consolidated list of all actions and the measurement framework. Fig. 1. Structure of the I-RAP for viral hepatitis, HIV and STI, 2022–2026 Sexually transmi�ed infec�ons strategy HIV strategy Viral hepa��s strategy Chapter 1 – Global and regional integrated elimina�on agenda Chapter 4 – HIV Chapter 3 – Viral hepa��s Chapter 5 – Sexually transmi�ed infec�ons Chapter 6 – Implemen�ng the Integrated Regional Ac�on Plan Annexes Chapter 7 – Monitoring and evalua�on Chapter 8 – WHO Ac�ons to keep the I-RAP on track Chapter 9 – Financing of the Regional Ac�on Plan Chapter 2 – Shared ac�ons for a people-centred tailored response 1.2 Vision, goals, strategic directions and targets This section presents the vision, goals and strategic directions of the I-RAP. It also presents the main impact targets. Vision: The 2022–2026 WHO I-RAP shares a common vision to end the epidemics of viral hepatitis, HIV and STI in the SE Asia Region under the umbrella of UHC with a focus on PHC, health security as well as meaningful engagement of communities. Goal: To end the epidemics of viral hepatitis, HIV and STI as public health threats by 2030 in line with the SDGs and aligned to GHSS (2022–2030) and Joint United Nations Programme on HIV/AIDS (UNAIDS) Global AIDS Strategy (2022–2026) (Fig. 2). Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 4 Fig. 2. Vision, goals and strategic directions of the Integrated Regional Action Plan on viral hepatitis, HIV and STI, 2022–2026 SD 1. De liv er hi gh -q ua lity , ev ide nce -bas ed, pe ople-centred services SD2. Optimize system s, sectors and partnerships for im pact SD 3.G enerate and usedatatodrivedecisionsforactionSD4.Engageempo were dco mm un itie sa nd civ ils oc ie ty SD 5. Fo st er in no va tio ns fo r i m pa ct Vision: End epidemics and advance universal health coverage, primary health care and health security Goal: End AIDS and the pandemics of viral hepatitis and sexually transmitted infections by 2030 Viral hepatitis STI *Drivers of progress: Gender equity and human rights Financing; Leadership and partnership Integrated Regional Action Plan HIV Drivers of progress* Five strategic directions oriented around service delivery, health systems, strategic information, community empowerment and innovations provide the overall guiding framework for country actions to implement the strategies: ¤ Strategic Direction 1: deliver high-quality, evidence-informed people-centred services. Member States should use evidence-informed guidance and service delivery innovations to accelerate access to, and the uptake of, a continuum of high-quality essential services for viral hepatitis, HIV and STI and other related health services, tailored to meet the needs of diverse populations and settings, ensuring that no one is left behind. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 5 ¤ Strategic Direction 2: optimize systems, sectors and partnerships for impact. Countries need to take a systems-oriented approach that promotes synergies with PHC, health governance, financing, workforce, commodities and service delivery while also fostering multisectoral responses to social and structural determinants of health. Align and collaborate with partners including funders, academic and research institutions, professional bodies and private sector entities for maximum impact. ¤ Strategic Direction 3: generate and use data to drive decisions for action. It is important to gather, analyse and use evidence and data, with disaggregation by sex, age and other relevant population characteristics to monitor and evaluate progress. This should guide action, innovation and research and development and promote data transparency and accountability. ¤ Strategic Direction 4: engage empowered communities and civil society. Countries must take concrete actions to engage communities and civil society including key and affected populations and support their self-empowerment and pivotal role in advocacy, service delivery and policy- making. They should also ensure that services are culturally appropriate and responsive to community needs, address stigma and discrimination and tackle social and structural barriers. ¤ Strategic Direction 5: foster innovations for impact. In collaboration with partners, contribute to defining and implementing national, regional and global research and innovation agenda that give priority to developing new technologies, service delivery models and health system practices. These innovations will help to overcome key barriers to achieving desired progress to reduce viral hepatitis, HIV and STI. 1.2.1 Impact of achieving the I-RAP targets The I-RAP has identified key targets on coverage of different services by 2025 (described later in the document). Achieving these targets will be crucial to producing the desired impact by 2025 to pave the way for elimination by 2030. The impact of achieving the targets is depicted in Figs. 3, 4, 5, 6 and 7. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 6 Fig. 3. HIV incidence from new actions implemented under the I-RAP 2020–2026 vs no new actions, projected to 2030 0 20 000 40 000 60 000 80 000 100 000 120 000 140 000 160 000 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 Progress required to reach 2025 and 2030 targets for HIV new infec�ons: WHO SEARO region Annual number of people newly infected with HIV - current trend Annual number of people newly infected with HIV - ideal 2025 target 2030 target Epidemiological progress un�l the end of 2020 Projected impact of scaling up and achieving the 2025 targets Projected impact of scaling up and achieving the 2030 targets Fig. 4. HIV mortality trends from new actions implemented under the I-RAP 2020–2026 vs no new actions, projected to 2030 0 20 000 40 000 60 000 80 000 100 000 120 000 140 000 160 000 180 000 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 Progress required to reach 2025 and 2030 targets for people dying from HIV-related causes: WHO SEARO region Annual number of people dying from HIV-related causes - current trend Annual number of people dying from HIV-related causes - ideal Epidemiological progress un�l the end of 2020 Projected impact of scaling up and achieving the 2025 targets Projected impact of scaling up and achieving the 2030 targets 2025 target 2030 target Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 7 Fig. 5. Incidence and mortality of hepatitis B, WHO SE Asia Region 2020–2030 Incidence and mortality of hepa��s B, SEARO 2020–2030 Th ou sa nd s of in fe c� on s or d ea th s 0 50 100 150 200 250 300 2025 Progress in 2020 256 000 infec�ons Progress in 2020 820 000 deaths Target in 2025 130 000 infec�ons Target in 2030 60 000 deaths Target in 2030 42 000 infec�ons Target in 2025 100 000 deaths 2020 2030 Number of new infec�ons expected with incremental policy Number of new infec�ons without policy enforcement Number of new death expected with incremental policy Number of new death without policy enforcement Fig. 6. Incidence and mortality of hepatitis C, WHO SE Asia Region 2020–2030 Incidence and mortality of hepa��s C, SEARO 2020–2030 0 50 100 150 200 250 2020 2025 2030 Th ou sa nd s of in fe c� on s or d ea th s Progress in 2020 234 000 infec�ons Target in 2025 115 000 infec�ons Target in 2025 20 000 deaths Progress in 2020 38 000 deaths Target in 2030 10 000 deaths Target in 2030 80 000 infec�ons Number of new infec�ons expected with incremental policy Number of new infec�ons without policy enforcement Number of new death expected with incremental policy Number of new death without policy enforcement Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 8 Fig. 7. Incidence of four curable STI and syphilis from new actions implemented under the I-RAP 2020–2026 vs no new action, projected to 2030 2025 target 2030 target 0 10 000 20 000 30 000 40 000 50 000 60 000 70 000 80 000 90 000 100 000 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 Progress required to reach 2025 and 2030 targets for new STI infec�ons: SEAR Annual number of new STI - 1% increae per annum post 2020 Annual number of people newly infected with STI - ideal Epidemiological progress un�l the end of 2020 Projected impact of scaling up and achieving the 2025 targets Projected impact of scaling up and achieving the 2030 targets The regional targets provide a guide for national targets and should be adapted to each country context. Equitable progress towards the targets is required across all populations, and the I-RAP encourages disaggregated analyses of data by sex, age and other relevant population characteristics to track inequities and ensure that most aff ected and at-risk populations are not left behind. The I-RAP provides a comprehensive regional framework of shared and disease-specifi c actions to guide countries and partners in their eff orts to achieve the goals of ending these epidemics. One size does not fi t all. Individual countries are encouraged to select, set priorities for, and adapt these actions in relation to local epidemiological and health system contexts, while upholding fundamental human rights, including the cross-cutting principle of equity and non-discrimination in the availability, accessibility, acceptability and quality of health services, products, approaches and interventions. The optimal selection of actions and service delivery models in the country contexts should be aligned with broader national strategies within a UHC framework and be responsive to the needs of individuals and local communities. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 9 1.3 Regional situation and response in SE Asia The epidemics of viral hepatitis, HIV and STI and responses thereto are at different stages across the Region. 1.3.1 Progress in viral hepatitis Viral hepatitis is a serious public health problem that can cause chronic and potentially fatal complications, including liver cancer. Among the estimated 1.1 million people dying globally due to hepatitis each year, around 20% are from countries in the WHO SE Asia Region.6 The Region has an estimated 60 million [45–121 million] people with chronic hepatitis B and an estimated 10 million [8–19 million] with hepatitis C. Of the estimated 218 000 deaths due to viral hepatitis in 2019 in the Region, 81% are attributable to the chronic complications of hepatitis B and C (6). Unlike other communicable diseases, such as HIV and TB, hepatitis-related mortality has not declined significantly despite the existence of high-impact tools for prevention and treatment. Most Member States of the Region have an intermediate-to-low prevalence of hepatitis B in the general population. For hepatitis C, most have a prevalence in the range of 0.28–0.75%, except for Indonesia, Myanmar and Thailand, where it is more than 2%. The prevalence of hepatitis B is slightly higher in people who inject drugs (PWID), while for hepatitis C the prevalence is many times higher, with several countries having a prevalence of over 50% of PWID living with hepatitis C, as illustrated in Fig. 8. Fig. 8. Prevalence of HBV and HCV in PWID in comparison to the general population in Member States of the SE Asia Region (all values are in percentages)6 0.72 0.49 2.03 2.65 0.38 0.23 2.28 40.89 51.48 63.50 56.00 27.48 5.57 58.86 0 10 20 30 40 50 60 70 BangladeshIndia Indonesia Myanmar Nepal Sri Lanka Thailand HCV prevalence % in general popula�on HCV prevalence % in PWID 5.5 7.1 6.5 0.9 5.1 6.2 3.6 7.3 3.5 14.0 0 2 4 6 8 10 12 14 16 Bangladesh Indonesia Myanmar Nepal Thailand HBV prevalence % in general popula�on HBV prevalence % in PWID HBV – hepa��s B virus; HCV – hepa��s C virus Since 2017, Member States have been implementing the Regional Action Plan (RAP) (2016–2021) for viral hepatitis in SE Asia. This action plan focuses on eliminating viral hepatitis as a public health threat by 2030 by achieving the global targets of 30% and 10% reduction in incidence and mortality, respectively by 2020; and a 90% and 65% reduction for chronic hepatitis B and C, respectively by 2030. The plan provides an actionable framework for evidence-based, prioritized actions along five core interventions on prevention, diagnosis and treatment (Fig. 9). Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 10 Fig. 9. Gap analysis of progress in hepatitis B and C prevention, testing and treatment in SE Asia, 2020 (6) 87 34 77 94.8 29 3 9 0 7 4 20 3 0 128 7.5 0 4.5 16.8 4 36 20 5.2 143 79.5 81 75.5 56.2 Hep B vaccina�on (Hep B3) % HBV PMTCT (Hep BD) % Blood safety % Injec�on safety % Harm reduc�on (NSP) # Tes�ng HBV % Tes�ng HCV % Treatment HBV % Treatment HCV % Baseline Progress from baseline Gap (2030 targets) Commendably, almost all countries are now in the process of implementing national strategic plans (NSPs) that provide guidance on key prevention interventions as well as hepatitis testing and treatment. The Region achieved an overall coverage of 91% of three doses of the hepatitis B vaccine in 2019. Bangladesh, Bhutan, Nepal and Thailand have already achieved the 2020 hepatitis B control target. Eight countries now provide the hepatitis B birth dose (HepB-BD). During 2016–2019, the regional hepB-BD coverage increased from 34% to 54%. A very timely hepatitis B birth dose at the largest maternity hospital in Pyongyang The Democratic People’s Republic of Korea is committed to hepatitis B control through the respective strategy 2017–2025 and uses application of the timely birth dose vaccination as one of the key interventions. Since its introduction in 2003, coverage has been reported at over 95% and the achievements were confirmed in the 2017 Multi Indicator Cluster Survey, when vaccination cards confirmed 99.5% of babies had received the dose. The Pyongyang Maternity Hospital plays a particularly important role with its dedicated immunization unit and close coordination between the obstetrics and vaccination teams, ensuring that every newborn receives the hepatitis B birth dose within less than 12 hours after delivery. Over 10 000 babies are born every year in this tertiary facility. Being also a teaching hospital, midwives and nurses are educated for work in other parts of the country and women’s health-care services can be provided via telemedicine to hospitals and clinics outside of Pyongyang, including the promotion of the timely hepatitis vaccine birth dose and subsequent infant immunizations. Regional hepatitis B vaccination coverage has, however, been impacted by the COVID-19 pandemic, with the three-dose coverage and birth dose coverage decreasing to 85% and 51% in 2020, respectively (7). Direct-acting antiviral drugs, which can cure 85–95% of hepatitis C infections, are becoming more affordable in several of the Region’s Member States. Most countries in the Region are lagging on coverage of PWID with the number of syringes and needles to be provided as per the target of 300 per year by 2030, the regional average being just 157. Diagnosis and treatment progress are well below that necessary Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 11 to reach elimination, with only 10.5% of an estimated 60 million with chronic hepatitis B knowing their status and just 4.5% on treatment at the end of 2018. Similarly, only 6.9% of the estimated population of 11 million with hepatitis C knew their status and 23% of those (1.5% of the estimated population) had received treatment by end-2018 (8). 1.3.2 Progress in HIV against 2020 targets WHO SE Asia Region is committed to achieving the Sustainable Development Goal (SDG) 3.3 of ending the AIDS epidemic as a public health threat by 2030. Nevertheless, the Region did not reach the 2020 targets and is also currently not on track to end AIDS by 2030 (9). Decades of experience suggests that inequalities are preventing achievement of the targets. The Region has a concentrated HIV epidemic, with a low HIV prevalence of 0.2% among adults (15–49 years). HIV incidence per 1000 uninfected population has shown a 50% decline during 2010–2020 (from 0.1 in 2010 to 0.05 in 2020). As at the end of 2020, there were an estimated 3.7 million [2.8–4.4 million] people living with HIV (PLHIV) in the SE Asia Region, including 1.5 million (41%) women aged over 15 years. There were an estimated 100 000 [71 000–130 000] new HIV infections and 82 000 [55 000–130 000] AIDS-related deaths in 2020. An overwhelming majority of the estimated PLHIV are geographically concentrated in five countries – India, Indonesia, Myanmar, Nepal and Thailand. In addition, more than 90% of new infections in the Region occur in key populations and their partners, including women and girls. Despite significant progress in the AIDS response in the Region between 2010 and 2020, the 2020 targets have not been achieved. Epidemiological trends show that new HIV infections declined by 46% from 190 000 in 2010 to 100 000 in 2020 (RAP 2017–2021 target: 50 000). Similarly, HIV-related deaths declined by 64% from 230 000 in 2010 to 82 000 in 2020 (RAP 2017–2021 target: 45 000). Tuberculosis (TB) related deaths among PLHIV have also declined substantially by 72% between 2010 and 2020 against the target of 75% (9) (Fig. 10). At the end of 2020, 2.8 million (75%) PLHIV knew their status, 2.2 million (61%) were on ART and 2.1 million (58%) were virally suppressed. This achievement of 75-61-58 coverage fell short of the 90-90-90 target that translates into 90-81-73 along the care cascade. Fig. 11 shows cascade for children and adults separately. On the first 90, only 75% PLHIV knew their status. On the second 90, ART coverage increased 3.6 times from 17% in 2010 to 61% in 2020, which is still short of the target of 81%. Out of 2.2 million on ART, nearly 1.5 million PLHIV received viral load testing, of whom 96% were virally suppressed. HIV incidence is highest among key populations, adolescents and young adults. Country-level data showed that the coverage of HIV prevention programmes among sex workers (SWs), PWID, men who have sex with men (MSM) and transgender persons remained below 80% in all countries except in India. Despite mature condom programmes in many countries, condom usage among PWID has remained low (22–66%). Also, the testing coverage among key populations is below 60% on average, with substantial disparity between countries. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 12 Fig. 10. New HIV infections and AIDS-related deaths trends in SE Asia Region, 2010–2020 (9) HIV infec�ons AIDS-related Fig. 11. Progress towards 90-90-90 along the care continuum, 2020, by age and sex (9) Despite many positive changes in the legal environment, some of the laws and policies that perpetuate stigma, discrimination, violence and other rights violations, especially for PLHIV and key populations, still remain in force across the Region. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 13 Reaching out to the “unreached” and keeping them HIV-negative Expanding community-led testing Every year, approximately 180 000 HIV tests are done in Nepal in the community setting by trained lay providers, i.e. community members from key populations. This community-led testing (CLT) approach was fi rst integrated into the national guidelines for HIV testing in 2017 and further strengthened in the 2020 testing guidelines. CLT is recommended as part of community-based testing and the “test for triage” strategy in which at-risk populations are off ered HIV testing by trained lay providers. The outreach workers and care and support providers from diff erent key population networks have been trained on CLT programme to provide HIV testing services to the community. As we work towards the last mile towards ending the AIDS epidemic, community-based interventions 1 Government of Nepal Ministry of Health and Population National Centre for AIDS and STD Control Teku, Kathmandu 2020 NATIONAL HIV TESTING AND TREATMENT GUIDELINES MAY 2020 (Photo Credit: NCASC, MoHP, Nepal) are an important method to reach the populations aff ected the most by the disease. Such approaches have been helpful for those who are otherwise reluctant or not able to access services due to several barriers. HIV self-testing services, innovative peer-based outreach and referral networks and digital platforms have been introduced to further expand the HIV services in the community. Pre-exposure prophylaxis: towards a comprehensive package of HIV prevention services Nepal is a country with a concentrated epidemic of HIV among key populations. In 2018, a demonstration study of HIV pre-exposure prophylaxis (PrEP) among key populations – female sex workers (FSWs), men who have sex with men (MSM) and transgender people was conducted, which led to the recommendation of PrEP being included in the National HIV Testing and Treatment Guidelines in 2020.* HIV PrEP is being currently implemented in 26 districts for FSWs, MSM, transgender people and their partners. More than 2000 clients were initiated on PrEP in the past six months. This innovative preventive service is now being planned on a nationwide scale up to expand coverage and provide a comprehensive package of quality preventive services for populations at risk of HIV. * National Centre for AIDS and STD Control. National HIV testing and treatment guidelines – May 2020. Kathmandu: Govt of Nepal, Ministry of Health and Population; 2020. Pic: HIV testing counselling for the client before prescribing PrEP (Photo Credit: NCASC, MoHP, Nepal) Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 14 1.3.3 Progress in STI Untreated STI can lead to long-term and potentially fatal outcomes including chronic pelvic pain, ectopic pregnancies, infertility, adverse pregnancy outcomes and neonatal death. STI are also associated with greater risk of HIV transmission, with ulcerative STI being associated with the highest risk. Most cervical cancers and a high proportion of some other anogenital and oropharyngeal cancers are caused by infection with human papillomaviruses (HPVs). STI have historically been a serious public health problem in SE Asia; and while the proportion of new infections has declined from a third of the total global estimate in the 1990s to 16% in 2019 (from 118 million to 60 million), the epidemiology of STI in the Region is highly heterogeneous. Insufficient data on STI from many countries limits both epidemiological assessment and control efforts (Fig. 12) (10). Fig. 12. WHO global estimates of four curable STI: proportion from the SE Asia Region 36% 35% 16% 16% 11% 0% 10% 20% 30% 40% 0 100 200 300 400 500 600 1995 1999 2005 2008 2012 SE AR p er ce nt o f t ot al Ne w In fe c� on s ( m ill io ns ) SEAR% SEAR Global SEAR – SE Asia Region Data on syphilis are more available and reliable than for other STI and can be used as markers of STI trends in general. Evidence of declining syphilis, as well as progress in eliminating MTCT of syphilis in some countries supports the feasibility of regional elimination of syphilis as a public health problem (10). However, congenital syphilis remains an important cause of adverse birth outcomes across the Region. In 2019 (using 2016 data), WHO estimated that in SE Asia, 78 000 pregnant women were infected with syphilis and there were 53 000 congenital syphilis cases including 28 000 adverse birth outcomes, making an estimated rate of 145 cases per 100 000 live births (11). Recent increases in syphilis among MSM in several countries also emphasises the importance of routinely screening key populations for syphilis and monitoring prevalence trends. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 15 The current programme response to STI varies greatly between countries of the Region. For example, Thailand and Sri Lanka have maintained strong commitment and funding for STI control over many years and have documented high levels of control, while many other countries face challenges in scaling up outreach to key populations, supporting clinical services and conducting basic STI surveillance. A key target in the previous Regional Action Plan for HIV in SE Asia (2017–2021) was the elimination of MTCT of HIV and syphilis (12). Three of 11 countries in the Region, i.e. Thailand, Sri Lanka and Maldives have achieved this. STI screening coverage among key populations and pregnant women is low. Between 2009 and 2016, only three countries of the Region reported over 90% antenatal clinic syphilis screening in any one year, three others reported almost no antenatal clinic screening and the remaining five countries reported a screening coverage of between 10% and 70%. Highly effective prevention initiatives including HPV vaccines are available, but access and coverage remain challenges. The last-dose coverage for HPV vaccination in the Region was 2% in 2020 as against a global coverage of 15% (13). Some countries of the Region have introduced HPV vaccination into their national programmes (14). HPV vaccine coverage has been impacted by the COVID-19 pandemic. The challenges for STI programmes include lack of resources and trained staff specific to STI at the sub- national level with national strategies largely oriented towards HIV; commodity gaps; lack of sustainable funding for community organizations; variable clinical services and lack of contact tracing. Legal and policy barriers to key populations having equitable access to health care, stigma and discrimination remain key concerns. Both domestic and external funding have declined for community organizations at the grassroots level over the past few years and demonstration projects have ceased to function due to lack of core funding support (15). 1.4 An Integrated Regional Action Plan to accelerate response towards elimination in the SE Asia Region 1.4.1 Rationale for integrating viral hepatitis, HIV and STI efforts The Seventy-fourth Session of the WHO Regional Committee adopted a decision to develop an integrated regional action plan for viral hepatitis, HIV and STI for the period 2022–2026. This I-RAP builds on the previous RAPs on viral hepatitis (2016–2021) (16) and HIV (2017–2021) (12) and has synergy with the regional flagship priorities on UHC and elimination of diseases. This action plan operationalizes the GHSS 2022–2030 and is aligned with a number of other global and regional initiatives including the United Nations General Assembly (UNGA) High-Level Meeting on HIV/AIDS in June 2021 and the SDG target 3.3 for ending the AIDS epidemic and combating viral hepatitis by 2030. Unlike some other infectious conditions that affect geographical locations as outbreaks and waves, viral hepatitis, HIV and STI mostly remain as silent epidemics. The vulnerabilities, inequities and lack of access to standard health care that persist among communities offer favourable conditions for sustained transmission of these infections. HIV became visible and prioritized for public health in the Region during Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 16 the decade 2001–2010. However, with the initial success of the ART programmes in reducing mortality and new infections, HIV programmes were relegated to a lower priority. On the other hand, hepatitis B and C, which affect a larger number of people than HIV and with higher mortality rates are yet to get noticed as a priority area requiring major public health interventions. The opportunity offered by direct acting antiviral drugs that can cure the majority of people with hepatitis C, is yet to be fully utilized. STI have significant morbidity too, albeit less mortality. Due to similar epidemiological characteristics and transmission dynamics as in HIV, STI were also addressed under the same programmes during the initial years of HIV response. Later, as the HIV programmes evolved to respond to the growing epidemic burden, STI lost importance. Bringing the three areas together for joint action through a common strategy has been visualized by WHO while formulating the GHSS on viral hepatitis, HIV and STI (2022–2030). As such, the I-RAP aligns with the GHSS for various components such as target setting, integrated implementation approaches and M&E. For the first time, the I-RAP has integrated three important communicable disease areas, instead of the individual RAPs that were followed till 2021. The need for such an integrated approach has been felt over several years. Moreover, each of them have separately failed to reach the 2020 targets and fully engage political and programmatic attention from Member States. The hepatitis component, specifically, had no donor funding or even dedicated domestic funds in most countries in the Region. While translating to national action plans, countries need to clearly articulate the rationale for integration as well as the process of integration, as these may be unique for each country. This I-RAP offers flexibility within the integrated framework, so that the required focus on specific aspects of the response can be ensured considering the unique issues in each, as well as the different stages of maturity of the disease programmes in Member States. Integration also refers to integrating efforts not only within these three diseases but also into the existing health infrastructure and health system of the country, including integrated strategies for prevention, testing and treatment across the health system to improve efficiencies and avoid duplication. Identifying areas of convergence and presenting an integrated model for delivery of services has been the central focus of this I-RAP. As programmes for the three disease areas are conducted under different verticals in most countries, issues of governance and integrated programme delivery assume key importance. Accordingly, the I-RAP has identified key areas that can be integrated or synergized to bring in efficiency in a client-friendly manner and to ensure availability of services closer to where people need them. Several aspects of the service delivery model for HIV programmes, such as community-led and community-based services, decentralisation, etc. could offer a good model for countries to design and successfully implement integrated programmes involving viral hepatitis, HIV and STI. For example, the opportunity to cure the majority of people living with chronic hepatitis C, which is not being fully utilized currently, could be better utilized by leveraging the infrastructure and social capital of existing HIV programmes through integrated approaches. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 17 1.4.2 People-centred action The burdens of viral hepatitis, HIV and STI overlap among some populations. The diseases share some common modes of transmission, which can be addressed together through common interventions. They are also shaped in similar ways by social and structural determinants of health, such that communities facing poorer socioeconomic conditions or discrimination (including discrimination experienced by key populations) experience greater vulnerability to infection and worse health outcomes. The I-RAP takes a people-centred approach. People-centred care is an approach to care that consciously adopts the perspectives of individuals, carers, families and communities as participants in, and beneficiaries of, trusted health systems that are organized around the comprehensive needs of people rather than individual diseases and one that respects social preferences (17). Promoting integrated service delivery that can benefit people with multiple health needs not only benefits the individuals but also the health systems. Services will be more sustainable on a longer term by reducing structural silos to enable efficiency gains and bring cost savings to clients and the system. This will also focus on a seamless and comprehensive continuum of services across prevention, testing and treatment as well as expanding and strengthening services through a primary health-care approach and intervention-specific, community-based services. This I-RAP provides an integrated approach to operationalizing those interventions necessary to best cater to the health needs of those affected, noting that the burden and distribution of viral hepatitis, HIV and STI vary between and within countries, and that health sector responses of both the public and private sector need to be adapted to different epidemiological and health system contexts. 1.4.3 Impact of COVID-19 and lessons for HIV, hepatitis and STI action Between March to May 2020, at least five Member countries reported significant dips in the number of HIV diagnosis and new treatment initiation. (% change in monthly diagnosis/ART initiation data compared to corresponding month in 2019). Three countries had challenges in maintaining adequate stocks of drugs. Activities related to field visit by outreach workers for prevention activities suffered a big setback due to lockdowns. COVID-19 also affected the key populations in many other ways including loss of earning. WHO provided guidance to countries through an advisory on maintaining essential HIV, hepatitis and STI services during the COVID-19 pandemic. Multiple month dispensing of ARV drugs and take away doses of OST were provided to limit the visits to ART centres. Digital platforms were used for capacity building exercise as well as for patient education and follow up of difficult cases. Community awareness sessions were conducted to remove certain apprehensions among People Living with HIV (PLHIV) and their vaccination was fast tracked through linkages with community peers. The COVID-19 pandemic altered the landscape of global health by shifting resources, drawing attention to the gaps in health systems and exposing and exacerbating the disparities and inequalities that make some populations more vulnerable to disease, including key populations which face pre-existing barriers to services. Primary prevention services have been impacted, with vaccination coverage, including of hepatitis B and HPV decreasing in 2020. Mental health and sexual and reproductive health service access, in particular, were compromised for key populations during this time. This has drawn attention to the Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 18 importance of integrating a rights-based public health response to mitigate the COVID-19 impact on public health and social measures and the need for a strong and well-supported health workforce to maintain service continuity in similar situations in future. The pandemic demonstrated the vital role of communities in meeting people’s needs during crises. It has also catalysed innovations in health and community systems, such as the rapid development and deployment of new vaccines and technologies and the expanded use of integrated diagnostics systems and platforms, health information systems, digital health solutions and self-care approaches. The challenges and potential opportunities emanating from the COVID-19 pandemic impact and response at the regional level have been detailed in the discussion paper COVID-19 and measures to ‘build back better’ essential health services to achieve UHC and the health-related SDGs and include a sustained focus on achieving UHC and responding to and preparing for health emergencies in order to maintain essential health services (18). Vaccination actions and targets will also be addressed in the Regional Vaccine Implementation Plan 2022–2026. Many important lessons from the COVID-19 pandemic will inform future responses to infectious diseases. Further, challenges such as demographic shifts, the growing burden of noncommunicable diseases (NCDs), climate change, population displacement and economic insecurity are also currently shaping the health and development context at the regional level. 1.5 The Integrated Regional Action Plan development process The I-RAP for viral hepatitis, HIV and STI (2022–2026), being the first of its kind in WHO SE Asia Region advocating an integrated response to these three infections, will entail a major policy shift for Member States and UN agencies, including WHO. While developing the I-RAP, the Regional Office for SE Asia has ensured that: ¤ the I-RAP is broadly in alignment with the GHSS (2022–2030) and other global instruments related to SDG 3; ¤ ownership for integration is built-in in the countries at political, administrative and technical levels; ¤ communities living with and affected by the three diseases see merit in an integrated response as one which will address access issues for vulnerable populations by bringing in community system strengthening as an important deliverable; ¤ while broadly indicating the resource requirements for the 5-year period, the I-RAP encourages countries to develop fully-costed NSPs with clear targets identifying the requirement of resources (both domestic and external) for implementation, to realize such national targets; ¤ a critical requirement for integration would be to evolve a unified M&E strategy by integrating the M&E systems for the three diseases, which presently exist in parallel. During the Seventy-fourth session of the Regional Committee, one Member State in the Region introduced a resolution titled “Beginning of the decade of action for ending viral hepatitis, HIV and STI as public health threats by 2030 in the South-East Asia Region”. After discussions, the Committee decided to request the Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 19 Regional Director to undertake a consultative process with Member States and other relevant stakeholders to develop an I-RAP on viral hepatitis, HIV and STI for the post-2021 period that will build on the current RAPs and be in alignment with the SDGs and the GHSS on viral hepatitis, HIV and STI (2022–2030). The development of the I-RAP started right after the Seventy-fourth Session of the WHO Regional Committee in September 2021 and has followed a systematic approach, as briefly described below (Fig. 13). ¤ As a background work, Member States and partners had provided their specific inputs on key components of importance to the Region during the SEARO-WPRO bi-regional consultations for developing GHSS on 15–16 June 2021. ¤ The Regional Office prepared an outline and concept paper for the I-RAP that was shared and discussed during the extended meeting of the Strategic and Technical Advisory Group (STAG) on viral hepatitis in November 2021. ¤ An online questionnaire was widely circulated to all stakeholders, put on the website and disseminated through social media for inviting inputs. ¤ A community dialogue was organized in conjunction with the World AIDS Day virtual event on 1 December 2021. This provided the opportunity for interaction with representatives of community-based organizations (CBOs) of key populations and people living with, or survivors of, the infections as well as civil society organizations (CSOs) and get their preliminary inputs. Their feedback on the present stage of response in respect of all three diseases and their suggestions for an integrated response were duly considered while drafting the I-RAP. ¤ A technical working group (TWG) was constituted with experts drawn from all the three disease streams to provide technical inputs for development of the concept paper and preparation of the I-RAP document. Two meetings of the TWG were held, in December 2021 and February 2022, respectively. The inputs from the TWG on the concept paper and the outline led to the development of this draft. Further, TWG members also participated in the virtual consultation with national programme managers and other stakeholders on 18–19 April 2022. ¤ A regional consultation was held on 18–19 April 2022 that included national programme managers of the three diseases from all Member States in the Region, health ministry officials, regional community-based organizations and CSOs and partners including Joint United Nations Programme on HIV/AIDS (UNAIDS), United Nations Children’s Fund (UNICEF), United Nations Office on Drugs and Crime (UNODC), United Nations Development Programme (UNDP), United Nations Population Fund (UNFPA), etc. and WHO country office focal points. ¤ A separate community interaction with a wider group of CBOs of key populations and affected populations was held to ascertain detailed views over and above what had been discussed in preliminary dialogues and online consultations (5 May 2022). The revised draft of the I-RAP was also put up on the website for further inputs in May 2022. ¤ Adoption of the I-RAP by Member States is planned at the Seventy-fifth Session of the Regional Committee in September 2022. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 20 Fig . 1 3. Pr oc es s o f d ev elo pm en t o f I- RA P Pr ep ar at or y w or k September June February October December January July August March April November September May 2021 2022 SE AR R AP fo r H IV (2 01 7 – 20 21 ) SE AR R AP fo r H EP (2 01 6 – 20 21 ) W HA d ec isi on to de ve lo p GH SS (M ay 2 02 1) Bi -re gi on al co ns ul ta � on ON G HS S, 1 5- 16 Ju ne 20 21 74 th R eg io na l C om m i� ee 2n d ST AG M ee � ng 2 4 No v 2 02 1 Qu es � on na ire de ve lo pe d an d cir cu la te d Co m m un ity se ss io n du rin g W AD , 1 D ec 20 21 1s t m ee � ng o f TW G fo r R AP , 7 De c 2 02 1 2n d m ee � ng of T W G fo r RA P, 11 M ar ch Dr a� R AP On lin e Qu es � on na ire pr ep ar ed a nd sh ar ed th ro ug h w eb sit e, so cia l m ed ia pl a� or m s M em be r St at e an d pa rt ne rs Co ns ul ta � on on R AP , 1 8- 19 Ap ril W ri� en an d on lin e fe ed ba ck on d ra � RA P th ro ug h w eb sit e Co m m un ity co ns ul ta � on , 5 M ay Fi na l d ra � , H LP , Ju ly 2 02 2 Ad op � on b y M S, 75 th R eg io na l Co m m i� ee , S ep t 20 22 In te rn al pr ep ar at or y w or k Fig . 1 3. Pr oc es s o f d ev elo pm en t o f I- RA P Pr ep ar at or y w or k September June February October December January July August March April November September May 2021 2022 SE AR R AP fo r H IV (2 01 7 – 20 21 ) SE AR R AP fo r H EP (2 01 6 – 20 21 ) W HA d ec isi on to de ve lo p GH SS (M ay 2 02 1) Bi -re gi on al co ns ul ta � on ON G HS S, 1 5- 16 Ju ne 20 21 74 th R eg io na l C om m i� ee 2n d ST AG M ee � ng 2 4 No v 2 02 1 Qu es � on na ire de ve lo pe d an d cir cu la te d Co m m un ity se ss io n du rin g W AD , 1 D ec 20 21 1s t m ee � ng o f TW G fo r R AP , 7 De c 2 02 1 2n d m ee � ng of T W G fo r RA P, 11 M ar ch Dr a� R AP On lin e Qu es � on na ire pr ep ar ed a nd sh ar ed th ro ug h w eb sit e, so cia l m ed ia pl a� or m s M em be r St at e an d pa rt ne rs Co ns ul ta � on on R AP , 1 8- 19 Ap ril W ri� en an d on lin e fe ed ba ck on d ra � RA P th ro ug h w eb sit e Co m m un ity co ns ul ta � on , 5 M ay Fi na l d ra � , H LP , Ju ly 2 02 2 Ad op � on b y M S, 75 th R eg io na l Co m m i� ee , S ep t 20 22 In te rn al pr ep ar at or y w or k © W HO SE AR O/ Aja ib S. 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Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 23 2. Shared actions for a people- centred tailored response This chapter describes shared interventions and service delivery models across viral hepatitis, HIV and STI under a UHC and primary health-care framework. All actions in this chapter should be considered in conjunction with disease-specific country actions presented in Chapters 3 (viral hepatitis), 4 (HIVs) and 5 (STI). Health systems encompass the public health sector as well as key non-state actors such as private sector health-care providers, civil society and CBOs that design and deliver health services. Health sector decisions regarding the integration of services across these disease areas should be considered in context and be informed by the status of national epidemics, health system priorities and consultation with service providers, individuals and communities. Integration efforts should not have unintended negative consequences. The progress achieved by disease-specific responses must be sustained, especially for the most affected and at-risk populations. Priority populations across viral hepatitis, HIV and STI The following populations are at a higher risk of acquiring HIV, viral hepatitis or STI and should be considered priority populations for prevention, diagnosis and treatment: ¤ Key and vulnerable populations ¢ Key and vulnerable populations include: ¢ people exposed through sexual transmission including young people and adolescents, MSM, SWs and their clients, transgender persons, people in prisons and closed settings, people whose sexual behaviour is mediated by drug or alcohol use and persons at risk of engaging in high-risk behaviour; ¢ people exposed through unsafe blood supplies and unsafe medical injections and procedures; ¢ people who inject and use drugs, especially those who are female children exposed through vertical MTCT or early childhood infection; ¢ pregnant and breastfeeding women; and ¢ women and girls, including adolescent girls and young women who face risks associated with gender inequalities and exposure to violence, in conjunction with increased biological risks on the basis of sex. ¤ Populations often overlooked in HIV, viral hepatitis or STI responses ¢ The populations often overlooked are: ¢ young people, including young key populations; Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 24 ¢ people of all ages who are less likely to use health services frequently; ¢ haemodialysis patients; ¢ migrants and mobile populations and people affected by conflict and civil unrest; ¢ indigenous peoples; and ¢ persons with disabilities. Each country should define the specific populations that are most affected and at-risk for viral hepatitis, HIV and STI within the local context. For some populations, intersectionality of challenges faced should be considered. Countries are encouraged to select, set priorities for and adapt the proposed country actions in relation to local epidemiological and health system contexts, while upholding fundamental human rights, equitable access to health and evidence-based practice. 2.1 Priority areas addressed through the I-RAP Integrated regional and national actions to address viral hepatitis, HIV and STI are dependent on strong governance at the national, provincial and local levels. As such, a cross-cutting priority area will be political advocacy and commitment from Member States, resulting in stronger governance to support the integrated model of service delivery at national and subnational levels. Integration of the three national programmes will give rise to a number of challenges that will need to be addressed. Given the multitude of potential actions needed across such a large health space, the I-RAP sets priorities in policy directives, implementation strategies, finding critical resources and developing monitoring indicators for the integrated response. Priority Key areas of action for SE Asia 1. Focus on populations that are most affected by and at risk of viral hepatitis, HIV and STI. These diseases share some common modes of transmission and social determinants and their disease burdens overlap among several populations. Affected populations also experience many forms of discrimination and marginalization. Comprehensive responses to empower affected populations including addressing stigma and discrimination and legislative barriers are needed. These groups may vary from country to country and may include special groups like indigenous peoples. Hence, context-specific populations should be identified and included. 2. Reduction in incidence of all three diseases through preventing transmission. Countries, and the Region as a whole have missed the incidence targets for 2020 set in the last RAPs. Concrete actions are needed to reduce the number of new infections to achieve 2025 targets. 3. Access to testing and treatment need to be scaled up substantially. This must be done across all three disease areas. Efforts should be made to maximize the number of people initiated on effective treatment following diagnosis through improved coverage and coordination across the continuum of prevention, testing and treatment services. Simplified guidelines and decentralized services including through the community should be the focus of action plans at the national level. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 25 Priority Key areas of action for SE Asia 4. Elimination of MTCT (EMTCT) of HIV and syphilis and movement towards triple elimination. All countries should prioritize elimination of MTCT interventions in their national plans, with special efforts to ensure that these interventions are taken up in all settings where infants are born, including at home and births in the private sector, where up to a third of all deliveries take place in some countries of the Region. Monitoring should also take place in these settings to enable progress, assessment and identification of opportunities for quality improvement. Triple elimination frameworks emphasizing the addition of hepatitis B to the elimination of MTCT of HIV and syphilis must be a priority. 5. Develop effective and inclusive governance structures. This is a critical determinant for the success of integration efforts. NSPs should prioritize, ab initio, the governance reform process for bringing the three national programmes under a common umbrella of governance. As such, NSPs must explicitly operationalize the process of integration at all levels. Integrated structures should be inclusive and participatory with collaboration across the sector including CSOs, the private sector and communities. Community systems strengthening and community-led monitoring systems should be integrated into governance structures. 6. Ensure adequate and sustained financing for the integrated programme for viral hepatitis, HIV and STI. Adequate and sustainable financing, especially for viral hepatitis, is challenging due to lack of dedicated donors and requires priority attention. There is need to allocate more domestic financing for prevention to reduce reliance on donors Currently, viral hepatitis, HIV and STI programmes have separate budget lines utilized and monitored by the different programmes. In the integrated mode, the NSP should reflect a single budget line for all the three diseases with separate funding streams for integrated actions and for individual interventions. Integration can benefit areas which have previously lacked funding, but ccareful articulation to allow equitable distribution based on need and impact will be required by countries. 7. Building the health workforce capacity. This will be a critical challenge for countries during integration of the three national programmes. Capacity-building of existing staff for increase of skill sets across three disease areas beyond regular work will have to form a fundamental part of health system strengthening. Training and retaining health co-workers need to be focused on. 8. Empower/strengthen community system strengthening. Differentiated service delivery approach need to adopted across all disease areas.Community health workers, including key population peer workers play a key role at the grassroots level and are resilient to working across various programmes. Their capacity should be strengthened through training programmes. Major gaps in service provision require expansion of community capacity to provide services to unreached populations. Adequate regulatory measures should be adopted to regulate their services, as is done for formalized health-care workers. They should be adequately compensated and protective equipment should be provided for infection control and maintenance of hygiene standards at par with formally qualified health workers. 9. Fostering innovations and embedding new technologies. This should be an area of priority for governments. In the last decade, several new technologies have been brought into the programmes, such as HIV pre-exposure prophylaxis (PrEP) , self-testing for HIV and viral hepatitis and use of digital technologies in implementation and monitoring of programmes. A technical sub-plan should become a part of the NSP identifying such emerging technologies for timebound operationalization. In addition, operational research should accompany the implementation of new initiatives to allow real-world evaluation. 2.2 Key targets across viral hepatitis, HIV and STI The I-RAP has identified key targets across the three disease areas in terms of regional coverage and impact targets. Tables 1 and 2 present the shared and disease-specific impact indicators and targets across viral hepatitis, HIV and STI. Additional disease-specific indicators and targets are presented in Chapter 3 (viral hepatitis), Chapter 4 (HIV) and Chapter 5 (STI), respectively. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 26 Table 1. Regional Impact indicators and targets for viral hepatitis, HIV, and STI by 2025 and 2030 Disease area Indicator Baseline –2020 Targets –2025 Targets – 2030 Viral hepatitis HBsAg prevalence among children younger than 5 years of age (proxy for incidence) 0.94% 0.5% 0.1% Number of new hepatitis B infections per year (incidence) 256 700 (13 per 100 000) 130 000 (5 per 100 000) 42 000 (2.5 per 100 000) Number of new hepatitis C infections per year (incidence) 234 100 (12 per 100 000) 115 000 (6 per 100 000) 80 000 (4 per 100 000) Number of new hepatitis C infections among PWID per year 8 per 100 3 per 100 2 per 100 Number of people dying from hepatitis B per year 179 000 deaths (9 per 100 000) 100 000 deaths (5 per 100 000) 60 000 deaths (3 per 100 000) Number of people dying from hepatitis C per year 38 000 deaths (2 per 100 000) 20 000 deaths (1 per 100 000) 10 000 deaths (0.5 per 100 000) HIV Number of people newly infected with HIV per year 140 000 41 000 35 000 Number of people newly infected with HIV per 1000 uninfected population per year (SDG 3.3.1) 0.05 0.04 0.025 Number of children 0–14 years of age newly infected with HIV per year 9000 3000 1500 Number of people dying from HIV/related causes per year (including disaggregation by HIV, cryptococcal meningitis, TB and severe bacterial infections) 94 000 32 000 30 000 STI Number of new cases of four curable STI in adults (15–49 years) per year ('000) 59 677 47 742 21 273 Number of new cases of syphilis in adults (15–49 years) per year ('000) 354 283 35 Number of new cases of gonorrhoea in adults (15–49 years) per year ('000) 21 059 16 847 2106 Congenital syphilis cases per 100 000 live births per year 145 <75 <50 HBsAg – hepatitis B surface antigen Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 27 Table 2. Regional Integration indicators and targets for viral hepatitis, HIV and STI by 2025 & 2030 Integration indicator Baseline 2020 2025 target 2030 target Number of countries that have taken a political decision to integrate the three national programmes of HIV, hepatitis and STI 2 8 11 Countries which have prepared fully- costed NSPs for the integrated response and identified finances for funding the NSPs 0 8 11 Countries where the three programmes have been brought under a common umbrella of governance 4 8 11 Countries where the health workforce of the three programmes have been retrained to work across all the three programmes 0 8 11 Countries where the community health workers (CHWs) have been given legal status and recognition at par with government health workers 1 3 11 2.3 Strategic Direction 1: deliver high-quality, evidence- based, people-centred services This section describes shared country actions across viral hepatitis, HIV and STI and other related health areas that can be integrated or are replicable across multiple disease areas for a more effective people- centred response. Actions in this section should be implemented by countries in conjunction with disease- specific country actions with a specific focus on including key populations. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 28 2.3.1 Integrated actions across viral hepatitis, HIV and STI No. Areas of implementation Country actions 1 Primary prevention intervention in sexual and reproductive health Primary prevention interventions are scaled up to eliminate sexual transmission of viral hepatitis, HIV and STI. ¤ The minimum set of necessary prevention interventions include: ¢ providing family planning services; ¢ correct and consistent use of male and female condoms and lubricants, with innovative programming; ¢ addressing the harmful use of alcohol and drugs in the context of transmission risk behaviour, including opioid substitution therapy (OST) and effective and evidence based substance use treatment; ¢ vaccination for vaccine preventable diseases (VPDs), HPV and hepatitis B with a focus on key and affected populations; ¢ promotion of sexual and reproductive health and well-being, with a focused approach for specific high-risk populations including MSM, transgender persons and PWUD; ¢ antiretrovirals for PrEP and PEP. ¤ Primary prevention includes comprehensive education and information about sexual and reproductive health and HIV prevention (19) consistent with global guidance adapted to local contexts and needs. 2 Harm reduction The national plan should include accessible harm reduction services as part of a comprehensive package of interventions for the prevention, treatment and care of HIV and viral hepatitis among PWID and for people who use stimulant drugs. ¤ The minimum harm reduction component package2 includes: ¢ provision of sterile injecting equipment through needle and syringe programmes, including low dead-space syringes (LDSSs); ¢ OST for people dependent on opioids; ¢ community distribution and provision of opioid antagonist medication (naloxone) to those likely to witness acute opioid overdose; ¢ targeted information and communication with a focus on key populations; ¢ testing, diagnosis and management of HBV, HCV, HIV, STI and other common infections, including for partners. ¤ Harm reduction interventions should be easily accessible and community friendly to promote acceptability. Some of the specific measures in this direction include take-home dosing, flexible timings, task sharing with community/lay providers, satellite OST centres in the community and secondary distribution of needles and syringes at community sites with trained collection of used needles and syringes by community members. 2 It is noted that the specific harm reduction requirements may vary depending on the key population. Harm reduction interventions also include those which reduce sexual transmission as detailed in Implementation Area 1 and as well as diagnosis and treatment detailed throughout this document. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 29 No. Areas of implementation Country actions 3 Integrated testing National programmes should implement integrated testing for HIV, viral hepatitis, STI, TB and other relevant communicable diseases as appropriate, feasible and cost effective for patient care. ¤ Integrated testing should be promoted through: ¢ use of multiplex diagnostic tools to streamline the collection and screening of biological specimens; ¢ rapid point-of-care multiplex tests for HIV, hepatitis B and C to assist in integrated testing and screening; ¢ community-based and self-administered integrated testing services; ¢ the use of common laboratory systems and networks; ¢ linking different laboratory networks through technological systems to promote national integration; and ¢ promoting use of self-testing for HIV/HCV/STI. ¤ Include implementation of human rights-based and gender-sensitive strategies for voluntary partner notification, including partners of key populations. 4 Integrated treatment National programmes should enhance opportunities for integrated viral hepatitis, HIV and STI care and treatment. This should include micro elimination efforts in specific populations such as: ¤ universal testing for viral hepatitis among HIV-infected individuals with referral to care and treatment; ¤ micro elimination of hepatitis C infection among PLHIV and in closed settings; ¤ ensuring that all individuals with hepatitis B–HIV, hepatitis C-HIV coinfection are receiving appropriate regimens to treat both infections; ¤ initiating screening programmes in key populations for STI, especially those affected or living with viral hepatitis or HIV; ¤ operationalizing integrated treatments with shared prescriptions and dosing, including substance use pharmacotherapy programmes; ¤ promoting and implementing treatment as prevention for all diseases. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 30 No. Areas of implementation Country actions 5 Stigma and discrimination in health-care settings National programmes should work to eliminate stigma and discrimination in health-care settings and strengthen accountability for discrimination- free health care, with particular focus on the stigma and discrimination experienced by affected people including key populations, or based on sex, gender, sexual orientation, drug use, sex work or other factors. National programmes should include: ¤ regular training for all health-care staff to enhance their knowledge of these diseases, address misconceptions and underlying fears and raise awareness about the harmful consequences of stigma and discrimination, including delayed health service utilization and health inequalities; ¤ development and monitoring of standards for health-care workers to ensure that all patients are treated with respect, dignity and compassion; ¤ health-care workers should be educated about patients’ rights as well as their own, and about how to sensitively provide care to all patients, especially key and most-affected populations; ¤ increased efforts to address stigma and discrimination experienced by health-care workers, including those who may themselves be living with HIV, viral hepatitis or STI; ¤ consideration of referral in the case of discrimination for those seeking redressal, including access to legal and mental health services. PEP – post-exposure prophylaxis; PWID – people who inject drugs Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 31 Hepatitis B community outreach A community-based outreach activity carried out in Timor-Leste on hepatitis B and C screening among the adult key populations demonstrated that they could achieve a high testing coverage to the tune of 84% for hep B (4196/5000) among key populations including people living with HIV (PLHIV) and uniformed personnel/National Police of Timor-Leste (PNTL). Hepatitis B positivity rate ranged at 3% for uniformed personnel/PNTL, 5% among key populations (female sex workers [FSWs], men who have sex with men [MSM], and transgenders [TGs]) to as high as 7% among PLHIV. Also, community-based organizations achieved an overall 71% coverage of the first dose of hep B vaccination. A coverage of around 82% among FSWs and 89% among PLHIV was achieved among those found to be hepatitis B negative. All 4196 participants were negative for hepatitis C. The high burden of hepatitis B, as demonstrated by this project, paved the way towards getting more attention in supporting the viral hepatitis programme. Currently, the country has moved towards an Integrated HIV, Hepatitis and STI National Strategic Plan (2022–2026). Besides, to ensure continuity of services during the COVID-19 emergency, and as per the earlier request from MoH for support for ARV, hepatitis B vaccines and viral load cartridges, hepatitis B treatment, HIV self-testing kits, and HIV pre-exposure prophylaxis (PrEP) drugs among key populations, WHO facilitated procurement and supply of these essential health products for the National AIDS Programme. Photo Credit: WHO country office, Timor-Leste Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 32 2.3.2 Linking integrated HIV, hepatitis and STI action to other health areas No. Areas of implementation Country actions 6 National Inter- programmatic linkage strengthening The national programme should include structural linkages to other disease- specific programmes to promote a people-centred approach to prevention, diagnosis, care and treatment of viral hepatitis, HIV and STI to enhance integrated management and early diagnosis and treatment of coinfections. ¤ Implement national health workforce literacy in prevention, diagnosis and treatment of viral hepatitis, HIV and STI across the health sector to promote coordinated care and management across these diseases. ¤ Linkages should be provided to national or state-based social welfare programmes. Key health programmes to be linked are as below: ¤ Communicable and noncommunicable diseases ¢ individuals with chronic viral hepatitis or HIV are linked to care for other NCDs including cardiovascular disease, diabetes, chronic lung disease, hypertension, etc. ¢ integration between viral hepatitis and cancer programmes as well as strengthened surveillance ¢ cervical cancer among women living with HIV; ¤ VPD programmes including HBV, HPV and COVID-19; ¤ TB ¢ prevention, diagnosis and treatment for TB in HIV and viral hepatitis-affected communities and the reverse, given shared population links; ¢ co-management of treatment where there is coinfection, to improve outcomes and reduce adverse clinical events during treatment; ¤ Hepatitis C ¢ People who use drugs are at much higher risk of Hepatitis C and HIV coinfection and there is need to focus on the same with close linkages across the intervention programme for both ¤ Sexual and reproductive health services integrated with or having programmatic linkages to HIV, viral hepatitis and STI services, including provision of integrated services; ¤ Mental health services ¢ strong linkages between services for mental health and HIV, hepatitis and STI should be established and maintained; ¢ prevention, screening, care, and referral to mental health services for further treatment and support can be integrated into services for viral hepatitis, HIV and STI; ¤ Substance use treatment services, including OST, treatment for stimulant and alcohol use disorders as well as rehabilitation programmes. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 33 No. Areas of implementation Country actions 7 Principles of service delivery across viral hepatitis, HIV and STI Particular attention should be paid to the needs of individuals with disabilities and those affected by violence and gender equality across all areas of service delivery. To achieve these aims, national programmes should include various aspects. ¤ Promote disability-inclusive programming and ensure that HIV, viral hepatitis and STI services are accessible to people with disabilities through the active participation and engagement of people with disabilities in planning and decision-making. ¤ Prevent and respond to all forms of gender-based violence, including sexual violence, through: ¢ implementation of the four pillars of action specified in the WHO global plan of action on health systems response to violence (20) including: ¢ preventing all forms of gender-based violence; ¢ provision of comprehensive health services for survivors (21); ¢ Implementation of these evidence-based interventions should be guided by the WHO and UN package on RESPECTING women: preventing violence against women for policy-makers, which has been endorsed by 12 other UN, bilateral and multilateral agencies (22). ¤ Promote gender equity by integrating its promotion across all actions through: ¢ addressing key issues resulting in inequities that generate risk of infection, including female genital mutilation, child marriage and lack of sexual and reproductive decision-making autonomy; ¢ disaggregation of programmatic data of prevention, diagnosis and treatment services by gender; ¢ implementing national policies on viral hepatitis, HIV and STI that include specific references to addressing the gender needs of those living with or at risk for these communicable diseases, including transgender persons through gender-affirming care. ¤ Promote a human rights-based approach to implementing integrated action across the three diseases, including within the context of human rights obligations in law and practice. Implement this through: ¢ availability of voluntary and accessible testing and treatment; ¢ evidence of confidentiality and privacy in disease status and treatment; ¢ evidence of absence of discrimination (for employment status, access to education, housing and social benefits); ¢ evidence of the absence of drug use, sexual orientation status, incarceration experience, immigration status or profession as a criterion for exclusion from testing and especially treatment; ¢ decriminalization of populations at risk or most affected by viral hepatitis, including PWUD, SWs and MSM. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 34 2.4 Strategic Direction 2: optimize systems, sectors and partnerships for impact This section describes UHC and PHC framing integrated actions to strengthen health service delivery and optimize health system functioning in collaboration with partners. The actions in this section should be implemented in conjunction with disease-specific actions. No. Areas of implementation Country actions 8 UHC Essential viral hepatitis, HIV and STI services are included as part of UHC. These essential services are included in national priority health benefit packages, supported by adequate financing, resulting in access for clients without financial hardship. 9 Primary health care and decentralization Incorporation of viral hepatitis, HIV and STI services into PHC systems is critical to decentralizing the essential components of prevention, diagnosis and treatment packages. This will optimize the health system’s ability to implement action towards elimination. ¤ Integrated viral hepatitis, HIV and STI services and their key coinfections and comorbidities are to be incorporated into PHC platforms. ¤ Viral hepatitis, HIV and STI services are to be decentralized so that they are easily accessible through community-based service delivery. ¤ Develop simplified testing and treatment protocols to support task shifting/sharing between health-care professions. ¤ Develop hub-and-spoke models from tertiary and specialized services to support shared care and supported models at lower levels of the health system. For this, internet-based systems including telemedicine can be used. 10 Health-care Infection prevention and control Infection prevention and control initiatives seeks to prevent disease transmission, especially HIV and viral hepatitis in formal and informal health- care settings and other service settings. ¤ National health systems must ensure: ¢ safe medical injections and blood supplies; ¢ standard precautions, especially relating to hand hygiene, blood screening, personal protective equipment and waste management; ¢ airborne infection control measures for the prevention of diseases such as TB and COVID-19. ¤ National health systems should work towards reduction of transmission risk by: ¢ eliminating unnecessary injections; ¢ providing safety-engineered syringes for all medical injections; ¢ using established WHO-aligned protocols for the decontamination of medical devices; ¢ providing universal and comprehensive screening of blood products so that sources of potentially unsafe blood products are eliminated. ¤ Outside of health facilities, interventions and national regulations are implemented to prevent unsafe injections and transmission through contact with bodily fluids in the informal health sector and in services such as tattooing, piercing and beauty care. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 35 No. Areas of implementation Country actions 11 Use of digital technology and telemedicine ¤ Implement telemedicine within the health system for service delivery. ¤ Use innovative methods to better understand the health needs of target populations, including virtual mapping and online surveys. ¤ Enhance the use of targeted client communication, such as for young people or individuals who may avoid in-person gatherings because of concerns about stigma and discrimination. ¤ Provide linkages across the digital health architecture of the national health system to enhance efficiencies and communication. ¤ Implement opportunities to access digital services for people who may not have access to digital technologies. 12 Equitable access in closed, humanitarian and other emergency settings ¤ Access to HIV, viral hepatitis and STI services should be ensured for mobile and displaced populations, or for those dislocated from regular services. ¤ Ensure continued access for affected persons in emergencies and in humanitarian settings when health service delivery is disrupted. ¤ Health-care services in prisons and other closed settings, such as detention centres, should be equivalent to those available to the broader community, in accordance with the United Nations Standard Minimum Rules for the Treatment of Prisoners (the Nelson Mandela Rules) (23). ¤ Continuity of these services should be ensured when people move within and between these settings and the broader community. 13 Sustained and targeted national financing3 National financing for viral hepatitis, HIV and STI should avoid fragmented funding, maximize the efficient use of resources and minimize overall catastrophic health expenditures for households. The following actions can optimize financing: ¤ health budget should include optimized domestic funding, complemented, where necessary, by external sources; ¤ aligning of domestic funding for viral hepatitis, HIV and STI packages with essential interventions for each disease area; ¤ budgeting for viral hepatitis, HIV and STI should be reflected in the costing planning and budgeting of essential health services including in the health insurance benefit packages; ¤ financing efficiencies be integrated into health service financing, including pooling funds from multiple financing sources; ¤ price reduction strategies should be implemented with a focus on diagnostics and medicines, including use of pooled purchasing mechanisms and partnership with the private sector. 3 More details available in Chapter 9 “Financing of the Regional Action Plan”. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 36 No. Areas of implementation Country actions 14 Essential health commodities National health systems require availability of essential health commodities for viral hepatitis, HIV and STI. The following actions are suggested to ensure availability of essential health commodities: ¤ expediting a national registration mechanism for new products, where recommended; ¤ supporting generic domestic markets in commodities, including medicines; ¤ promoting voluntary technology sharing on mutually agreed terms and addressing intellectual property-related barriers by leveraging the use of Trade-Related Aspects of Intellectual Property Rights (TRIPS) flexibilities; ¤ engaging in direct price negotiations with manufacturers and the sharing of product prices; ¤ implementing integrated supply chain management and logistics information systems to ensure timely and accurate data regarding commodity needs and consumption for decision-making and accountability. 15 Health system strengthening National systems require the availability of health workers with the required competencies and training at all levels of care to deliver people-centred prevention, clinical and supportive services across the continuum of care, tailored to the epidemic and country context. The following actions support this goal: ¤ comprehensive national health workforce plans should optimize the utilization of the existing workforce including CHWs and advance multi-disciplinary team-based care; ¤ disease-specific needs should be quantified and balanced against the need for generalist health service provision, ensuring the quality of care; ¤ national capacity-building, ongoing training and supportive supervision for health workers, including initial and postgraduate training of facility-based workers and CHWs at all levels on sexual health and the needs of people affected by viral hepatitis, HIV and STI; ¤ provide continuing professional development to the health workforce on viral hepatitis, HIV and STI consistent with up-to-date clinical practice guidelines (including e-learning opportunities) and enhance supportive supervision systems. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 37 No. Areas of implementation Country actions 16 Legal, regulatory and policy reform An enabling legal and regulatory environment is critical for implementation of policies that will allow disease elimination. The following actions will help to achieve such an enabling environment, where appropriate: ¤ Undertake review and reform of any restrictive legal and policy frameworks to enable equitable access to health services for viral hepatitis, HIV and STI, especially to the most affected and at-risk populations. ¤ Undertake legal, regulatory and policy reform and provide alternatives to coercive sanctions for PWID, SWs and people in same-sex relationships seeking care, including harm reduction services. ¤ Create an enabling, safe environment for key populations by reorienting towards evidence-based legal frameworks and policies that promote human rights, harm minimization and discourage stigmatization and discrimination. ¤ Provide mechanisms and support for legal redress for individuals living with viral hepatitis, HIV or STI when it impacts prevention diagnosis and treatment access or quality. ¤ New initiatives should be implemented through supportive legislation that upholds the implementation of evidence-based interventions, promotes and protects human rights and gender equity and reduces stigma and discrimination. These initiatives should support the provision of legal aid for people in need. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 38 2.5 Strategic Direction 3: generate and use data to drive decisions for action This section describes shared approaches to strengthen health information systems for better data availability, use and accountability, including person-centred monitoring. The actions in this section should be implemented in conjunction with disease-specific actions. No. Areas of implementation Country actions 17 Strategic information and other data ¤ There must be regular national reporting on prevention, including vaccination, testing, treatment, financing and performance across the three diseases, including in decentralized systems using DHIS 2 platform. ¤ Implement disaggregation of HIV, viral hepatitis and STI surveillance data by sex, disability, age and other relevant population characteristics, supplemented by information from community-led monitoring. ¤ Utilize standardized reporting or data tools where possible. Existing WHO tools could be adapted for local use. ¤ Work towards the use of digital data reporting systems to facilitate integration and information exchange, including between clinical data management platforms or facility-based reports and population- level data. ¤ Strengthen public–private partnerships in data and promote data sharing in compliance with security and data protection standards to ensure harmonized service quality standards. ¤ Ensure systems maintain data confidentiality and security. Data collection efforts should not compromise confidentiality, cause distress or exacerbate stigma. ¤ Develop adequate information dissemination systems such that data from the three disease areas are used to drive evidence-based programme planning, advocacy and quality service delivery. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 39 No. Areas of implementation Country actions 18 Community-led monitoring (CLM) Community led or community-based monitoring is any type of monitoring led by communities. CLM is an accountability mechanism for viral hepatitis, HIV and STI services and the health system in general to provide civil society participation in reporting as a key quality feedback mechanism for programmes (24). This may include: ¤ programme monitoring ¤ community scorecards ¤ patient satisfaction surveys, compliant and other feedback mechanisms from the end-user groups ¤ treatment observations and social audits ¤ engagement of patient groups or peer educators. These community led or community-based feedback systems should be: ¤ headed by someone from the community and community led, including and ensuring diversity within the community groups; ¤ focused on action and accountability; ¤ independent, empowering and sustainable; ¤ collaborative – promoting good partnerships; ¤ technically supported in terms of data collection, analysis and sharing; ¤ routine, systematic and standardized; ¤ integrated with mainstream national responses; ¤ show results; ¤ Be systematically reviewed. 2.6 Strategic Direction 4: engage empowered communities and civil society This section describes approaches to engage and support the empowerment of communities, CSOs and affected populations in advocacy, service delivery and policy-making and initiatives to enhance service delivery and tackle social and structural barriers. Civil society and CBOs have played a leading role in HIV-related advocacy, service delivery and accountability since the early stages of the HIV response. More recently, they have also successfully advocated for stronger responses to viral hepatitis and STI. The COVID-19 pandemic spurred CBOs worldwide to step up their innovative efforts to bring services closer to people in need within an environment of trust. The meaningful participation of people with HIV, viral hepatitis or STI and their families and communities is of critical importance in determining, developing and implementing national and subnational policies for affected communities and should be actively promoted. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 40 No. Areas of implementation Country actions 19 Foster community and civil society leadership Full engagement with communities and civil society is necessary for elimination goals to be realized. ¤ Ensure meaningful involvement of key populations, community organizations and people, including women living with HIV and hepatitis in advocacy, service delivery, policy-making, M&E and initiatives to address social and structural barriers to services. ¤ Ensure affected community representation in the national HIV, viral hepatitis and STI taskforce or equivalent. ¤ Drawing on community engagement and empowerment strategies in the HIV field, health systems should elevate the role of communities and community-based service providers as partners in promoting sexual health. ¤ National programmes should include peer-led or peer navigation interventions for key populations who are not reached effectively through traditional approaches, including rural and marginalized populations. ¤ Make domestic resources available to support, build capacity and ensure sustainability of CBOs. ¤ Ensure that the community-based health workforce operates within an environment of adequate regulation, training, supervision and support and is strongly linked to formal health services. ¤ Learn from innovative approaches introduced as part of care during the COVID-19 pandemic to simplify service delivery and meet the needs of communities. ¤ Include social contracting as a mechanism for engaging communities and delivering services to affected communities. 2.7 Strategic Direction 5: foster innovations for impact This section describes shared approaches to foster and disseminate innovations for accelerated impact. The points in this section should be implemented in conjunction with disease-specific actions. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 41 No. Areas of implementation Country actions 20 Strengthening development and adoption of innovations ¤ Across viral hepatitis, HIV and STI, countries should foster the early adoption and inclusion of innovations, including: ¢ new diagnostic technology which enhances screening and testing programmes, including HIV and hepatitis self-testing and the use of dried blood spots; ¢ new technologies to improve adherence to treatment of viral hepatitis, HIV and STI, including but not limited to such interventions as web-based refills, remote testing and adherence reminders; ¢ new preparations of existing treatments, including long-acting formulations; ¢ innovations in roll out for testing, prevention, care and treatment, including PrEP scale up, the use of telemedicine and other internet-based technologies. ¤ Adopt, evaluate and rapidly scale up innovative testing and treatment technologies and approaches which are effective for key populations, e.g. utilizing one-stop or single window services. ¤ Data-driven and evidence informed innovations must also be community-friendly. 21 Build partnerships to support innovation and research ¤ National programmes should encourage participation in collaborative research with national and international research partners to drive innovation in therapeutics, vaccines and HIV and HBV cure. ¤ Support operational research/implementation science to make delivery of interventions through health systems more efficient and impactful for countries. ¤ Build partnerships in the domestic and international innovation space across the three disease areas, including with the private sector, to support the roll out of innovations in the Region. 2.8 HIV, syphilis and hepatitis B triple elimination Triple elimination refers to the elimination of major communicable diseases associated with MTCT, specifically HIV, syphilis and hepatitis B. Triple elimination targets can be achieved only when access to quality reproductive, maternal and child health-care services is ensured and used by all women, children and their families. Mother-to-child or vertical transmission of HIV, hepatitis B and syphilis can be effectively prevented by similar strategies, including antenatal screening for HIV, syphilis and HBV, syphilis treatment of mothers and their infected infants, HBV and HIV antiviral treatment or HBV prophylaxis for eligible mothers, and HBV infant prophylaxis (including birth dose vaccination). The funding and organization of antenatal care (ANC) services and programmes at the national level provides an opportunity for concrete integrated service delivery to optimize programme efficiencies, deliver quality people-centred care and improve outcomes for both mother and child. The I-RAP impact and programme targets for HIV, syphilis and hepatitis B are consistent with those of the global criteria for countries to validate the elimination of MTCT detailed in the recent WHO guidance. The Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 42 global validation criteria for elimination are listed in Annexure 2. In all three areas, it is the combination of antenatal screening and treatment combined with care of the neonate that results in the elimination of transmission. In addition, for hepatitis B, there also is a safe and effective vaccine that assists in stopping transmission when given within 24 hours of birth. Provision of the criteria and processes for measuring progress towards and achieving elimination through assessment of impact and programmatic indicators for triple elimination are detailed in the Global guidance on criteria and processes for validation: global guidance for the elimination of MTCT of HIV, syphilis and hepatitis B virus (Third edition) (25) and the Governance guidance for the validation of EMTCT of HIV and syphilis (26). No. Areas of implementation Country actions 22 Triple elimination of HIV, syphilis and hepatitis B virus and the prevention of new infections among children and adolescents ¤ National programmes include key essential services to promote triple elimination of HIV, syphilis and hepatitis, specifically: ¢ rights-based and gender-sensitive family planning; ¢ testing for HIV, syphilis and hepatitis B virus in ANC; ¢ prompt and efficacious interventions to treat pregnant women who test positive and to prevent transmission of the infection(s) to their infants; ¢ counselling for pregnant women and their partners; ¢ safe delivery; ¢ follow-up timely hep-B BD +/- hepatitis B immunoglobulin (HBIg) and completion of the 3-dose series of hepatitis B vaccine for all children, with particular emphasis on follow up for exposed infants; ¢ follow up of HIV-exposed infants and early infant diagnosis; ¢ assessment, treatment and follow up of syphilis-exposed infants – optimal infant feeding; ¢ follow-up treatment and care for mothers and families. ¤ National action should have the goal of preventing all new infections due to viral hepatitis, HIV and STI among children. ¤ National programmes should promote integrated approaches with sexual and reproductive health programmes for HIV prevention and family planning. ¤ Measuring of progress and validation of elimination should be undertaken in line with WHO guidelines 23 Linkages to maternal and child health programmes Triple elimination targets can be achieved only when access to quality services for sexual and reproductive health care and maternal and child health are assured and all women, children and their families use these services. ¤ National programmes for HIV, syphilis and hepatitis B should implement concrete linkages towards integration with maternal and child health programmes at all levels of the health system. ¤ Access to these services should be offered to all women of reproductive age before or between pregnancies to reduce transmission of HIV, syphilis and hepatitis B during pregnancy. © W HO SE AR O/ Ch ris tin e M cN ab

Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 45 3. Viral hepatitis This chapter presents the aspects of viral hepatitis in the I-RAP 2022–2026. While acknowledging the importance of viral hepatitis A and E (27,28), both of which cause acute viral hepatitis, the strategy focuses primarily on chronic viral hepatitis B and C, given that these two infections, which may lead to cirrhosis and hepatocellular cancer, account for 96% of all viral hepatitis mortality. Hepatitis D coinfection or superinfection accelerates the progression of chronic liver disease, but only among people living with hepatitis B. Actions for countries in this chapter should be implemented in conjunction with and in addition to the integrated shared actions detailed at Chapter 2. 3.1 Key areas for urgent attention towards the regional elimination goal There is an urgent need to address the heterogeneity of hepatitis responses between countries, promote greater public and political literacy and awareness about viral hepatitis B and C prevention, testing and treatment and undertake mathematical modelling for epidemiological and economic impact assessment of national actions, i.e. “investment cases” for viral hepatitis B and C. This will help in advocacy with countries to allocate increased financial resources to viral hepatitis B and C including funding of testing and treatment through essential national health benefit packages. Urgent scale up of timely hepB-BD and linkage to mother-to-child triple elimination initiatives with HIV and syphilis are essential. A specific focus is needed on: (i) engagement of key populations through addressing structural barriers; (ii) urgent scale-up of harm reduction measures (needle and syringe programme and OST) to reach coverage targets; (iii) implementation of decentralized and simplified service delivery; and (iv) active participation of the community and civil society at all levels of policy and service delivery. 3.1.1 Viral hepatitis targets Table 3 presents the impact and programmatic coverage indicators and targets as well as policy milestones for viral hepatitis. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 46 Table 3. Regional impact and coverage indicators, targets and milestones for viral hepatitis by 2025 & 2030 Indicator Baseline–2020a Targets–2025 Targets–2030 Impact indicators HBsAg prevalence among children younger than 5 years of ageb (proxy for incidence) 0.94% 0.5% 0.1% Number of new hepatitis B infections per year (incidence) 256 700 (13 per 100 000) 130 000 (5 per 100 000) 42 000 (2.5 per 100 000) Number of new hepatitis C infections per year (incidence) 234 100 (12 per 100 000) 115 000 (6 per 100 000) 80 000 (4 per 100 000) Number of new hepatitis C infections among PWID per year 8 per 100 3 per 100 2 per 100 Number of people dying from hepatitis B per year 179 000 deaths (9 per 100 000) 100 000 deaths (5 per 100 000) 60 000 deaths (3 per 100 000) Number of people dying from hepatitis C per year 38 000 deaths (2 per 100 000) 20 000 deaths (1 per 100 000) 10 000 deaths (0.5 per 100 000) Coverage indicators Hepatitis B – percentage of people living with hepatitis B diagnosedc/ and treated (initiated vs viral load suppression) 10.5%/4.5% 60%/50% 90%/80% Hepatitis C – percentage of people living with hepatitis C diagnosed/ cured 9%/7% 60%/50% 90%/80% Percentage of neonates who have benefitted from a timely hepB-BD vaccined 54% 70% 90% Hepatitis B vaccine coverage among children (third dose) in those <1 year of age 91% 90% 90% Number of needles and syringes distributed per PWIDe (common HIV/viral hepatitis indicator) 157 200 300 Percentage of opioid-dependent PWID who receive OST 2.8–19.5%f 40% 40% Blood safety – proportion of blood units screened for bloodborne diseases 80% 100% 100% Safe injections – proportion of safe health-care injections 94.8% 100% 100% Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 47 Indicator Baseline–2020a Targets–2025 Targets–2030 Milestones Planning – number of countries with costed hepatitis elimination plans 2 11 11 Surveillance – number of countries reporting burden and cascade annually 3 8 11 Elimination of vertical (mother-to- child) transmission – number of countries validated for the elimination of vertical transmission of either HIV, hepatitis B or syphilis 3 5 11 Elimination – number of countries validated for elimination of hepatitis C and/or hepatitis B 0 2 11 Integration – proportion of PLHIV tested for/and cured from hepatitis C Unreported 60%/50% 90%/80% a Latest data for end 2020. Some targets use data from 2019 because of COVID-19 related service disruptions in the data reported for 2020. b Please note that the targets in this table are based on global targets and should be adapted to set targets for countries in relation to the national context. For example, in some countries a target for HBsAg prevalence among children younger than 5 years may be less than 0.1% or 0.2%, although the overall regional target should be 0.1%. Baseline data may not be available in all countries. c Denominator is estimated number of people living with hepatitis B virus (standardized population estimate). d In addition, the proportion of infants younger than 12 months of age who received the third dose of hepatitis B vaccine should also be measured as well as for other indicators for preventing vertical transmission such as maternal testing and prophylaxis, antiviral, as well as HBIg to the neonate. Note that the hepatitis B vaccination coverage achievements here are for 2019. e As part of a comprehensive harm reduction strategy and in line with national priorities. f Wide variation between countries in the Region (not all countries reporting). 3.2 Core regional hepatitis targets and additional targets for 2025 ¤ Increase timely birth dose to 70% of live births by 2025 ¤ Reduce HBsAg prevalence in 5-year-olds to 0.5% by 2025 ¤ Reduce the number of new HBV infections to 130 000 (7/100 000) and new HCV infections to 115 000 (6/100 000) ¤ Reduce deaths from HBV to 100 000 (5/100 000) and HCV to 20 000 (1/100 000) ¤ Increase markedly from baseline, coverage of combination harm reduction interventions to PWID and PWUD ¤ Increase – through integration – the proportion of PLHIV tested for and cured from hepatitis C and those with HBV and HIV on treatment with HBV active regimens. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 48 3.3 Strategic Direction 1: deliver high-quality, evidence- based, people-centred services This section describes viral hepatitis-specific areas of implementation and necessary country actions along the continuum of viral hepatitis prevention, diagnosis, care and treatment services. Service delivery must be tailored to the needs of different affected populations and in accordance with different epidemiological contexts. Populations at higher risk for viral hepatitis in SE Asia ¤ PWID ¤ People in prisons and other closed settings ¤ Gay men and other MSM, especially those living with HIV ¤ Sex workers ¤ Children of mothers with chronic hepatitis B or hepatitis C infection, especially if living with HIV ¤ Family members of persons living with hepatitis B ¤ Mobile and migrant populations from high and intermediate endemic countries ¤ People with historical health-care exposure through unsafe blood supplies, unsafe medical injections and other health procedures including haemodialysis. 3.3.1 Delivering the continuum of viral hepatitis services The continuum of viral hepatitis services provides an organizing framework for implementing essential interventions that comprehensively address people’s needs. Services should be organized in ways that promote early engagement in care, maximize retention and treatment adherence; and in the case of HCV, prevention reinfection. The retention cascade should be monitored to identify areas in which programmatic improvements are needed (Fig. 14). Fig. 14. The service engagement cascade for hepatitis B virus and hepatitis C virus Pe rc en ta ge o f P LH IV 0 20 40 60 80 100 120 Reached by preven�on ac�vi�es (reaching all priority popula�ons) Diagnosed Treatment Virally supressed (hepa��s B virus) or cured (hepa��s C virus) The hepa��s B virus and hepa��s C virus service con�nuum Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 49 No. Areas of implementation Country actions 24 Viral hepatitis intervention packages National programmes should define the core viral hepatitis intervention package which is aligned with UHC benefits packages and linked with PHC, where feasible and relevant. ¤ National programmes should review data to determine the optimal mix of prevention interventions for different populations and locations. ¤ Core interventions of the viral hepatitis package include: ¢ timely newborn and childhood hepatitis B vaccination to achieve national targets, including subnational coverage; ¢ EMTCT for HBV including universal testing of pregnant women, with universal timely birth-dose for their neonates; ¢ harm reduction (needle and syringe programme including LDSSs and OST for PWUD/PWID); ¢ screening for HBV and HCV followed by confirmation of viraemia and linkage to care where positive; ¢ Screening for HIV and other STI as part of viral hepatitis care; ¢ antivirals for HBV and HCV; ¢ targeted prevention, including HBV vaccine and programmes for key populations – MSM, transgenders, SWs and PWUD; ¢ efforts to build prevention, diagnosis and treatment literacy for hepatitis A, B, C, D and E across the general population, key and other vulnerable populations and health-care workers. 25 Elimination of viral hepatitis transmission through vaccination (HBV, hepatitis A virus [HAV]) The elimination of HBV through vaccination, both hepB-BD and B3 schedules, is critical for stopping HBV transmission. Full implementation of HBV vaccine programming includes the following: ¤ implementation of universal timely (< 24h) birth dose and HBIg to exposed neonates; ¤ treatment of pregnant women with high HBV DNA with antivirals (tenofovir) and HBIg to all exposed neonates; ¤ implementation of universal third dose of hepatitis B vaccine (hepB3) infant vaccine schedule (a total of three/four doses, including the birth dose); ¤ targeted HBV catch-up vaccination of key populations, health-care workers, those having frequent medical procedures (blood products, dialysis) and other non-infant populations, where cost effective; ¤ rapid (0, 7, 21 days and 1 year) and accelerated (0, 1, 2 months) hepatitis B vaccine schedules for specific populations where necessary to boost HBV vaccine coverage, including for catch-up programmes. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 50 No. Areas of implementation Country actions Hepatitis A and E are endemic in many areas of SE Asia. ¤ HAV vaccine should be offered under the following conditions: ¢ single dose administration in HAV outbreak contexts according to local epidemiology; ¢ consideration of implementation of single-dose HAV vaccine as part of routine infant vaccination programming in endemic areas, or in areas of transitioning epidemiology; ¢ consideration of approved hepatitis E virus (HEV) vaccine should be made in line with national guidance, where epidemiologically indicated. ¢ There is no vaccine available for HCV. 26 Viral hepatitis testing National programmes to include optimal combination of HBV and HCV testing approaches, including through clinical settings, community-based approaches or self-testing appropriate to the local context and available evidence. This entails the following: ¤ national plans to include HBV and HCV testing algorithms appropriate to the epidemiologic context, including for the general population and key populations; ¤ implement public awareness campaigns educating endemic and at- risk populations and health-care workers; ¤ implement simple, standardized and evidence-based viral hepatitis testing algorithms across all levels of the health system including non-specialists to support task sharing and shifting; ¤ expand access to testing through effective people-centred approaches and link people who are found to be positive to treatment and care services; ¤ offer hepatitis screening for family members of people living with chronic hepatitis; ¤ implement targeted HBV and HCV testing in key populations, including provider-initiated and self-testing with linkages to care and treatment and retesting for PWID (and other high-incidence populations); ¤ laboratory- and clinic-based reflex testing for viral hepatitis, e.g. to establish rapid diagnosis of HCV ¤ include viral hepatitis testing in integrated testing platforms for multi-disease approaches; ¤ ensure a reliable supply of quality-assured (e.g. WHO-prequalified and/or national regulator approved) diagnostics; ¤ implement timely reporting of testing results, centralized where appropriate, with interoperability between test reporting IT systems. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 51 No. Areas of implementation Country actions 27 Viral hepatitis treatment National programme to include treatment for all those with HCV and all those eligible for HBV treatment, especially persons with advanced disease and pregnant mothers with high viral load. This may include the following actions: ¤ strengthen linkages across the health sector to drive diagnosed individuals to early timely initiation of HBV and HCV treatment; ¤ implement national guidelines for treatment aligned with WHO guidelines for treating chronic viral hepatitis B and C infection and promote a simplified public-health approach; ¤ implement and scale up targeted treatment for populations with high HCV incidence including PWID to augment prevention measures; ¤ include treatment initiatives to cater for treatment of children and adolescents in accordance with WHO treatment guidelines, including adolescent-friendly services that also address psychosocial support and management of stigma for children and adolescents with hepatitis B and hepatitis C virus infection; ¤ programmatic focus on the elimination of HCV among PLHIV through a HCV–HIV coinfection micro-elimination initiative; ¤ build capacity at PHC level for HBV and HCV treatment, including through hub-and-spoke models of shared care and supervision; ¤ monitor the cascade of treatment and care to identify and address barriers to early linkage and retention in care. 28 Support for chronic hepatitis comorbidities, advanced liver disease and liver cancer Liver diseases requires special measures to optimize outcomes, including the management of comorbidities. ¤ Implement screening for common comorbidities in people with chronic hepatitis B or C infection, including for cirrhosis and hepatocellular carcinoma (primary liver cancer) and extrahepatic manifestations including diabetes. ¤ Screen for and offer treatment for medical conditions that exacerbate liver disease such as problematic alcohol use and metabolic syndrome, including obesity and hypertension. ¤ Make available more specialized services for individuals with advanced liver disease, including decompensated cirrhosis, transplantation and palliative services for end-of-life care. ¤ implement routine screening for primary liver cancer in individuals with chronic HBV and HCV infection; ¤ implement HBV, HCV and HDV screening for liver cancer patients where the primary cancer source is unknown; ¤ improve hepatitis diagnosis and treatment literacy among cancer services. ¤ Establish strong linkages between viral hepatitis and cancer screening programmes to allow early detection and effective treatment of hepatocellular cancer (HCC). Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 52 3.4 Strategic Direction 2: optimize systems, sectors and partnerships for impact This section describes viral hepatitis-specific priority actions to strengthen health service delivery and other health system functions including multisectoral collaboration. No. Areas of implementation Country actions 29 Decentralize hepatitis services Elimination of hepatitis requires widespread decentralization of hepatitis prevention, testing and treatment services to reach the whole population. ¤ Implement hepatitis services at the PHC level. ¤ Include hepatitis prevention, testing and treatment in prisons and other closed settings. ¤ Build capacity in non-specialists through capacity-building and task sharing in hepatitis testing and treatment. ¤ Encourage shared care for the management of complex cases, including through telemedicine services. ¤ Maximize the availability of harm reduction interventions to all subnational areas. 30 Scale up hepatitis financing in national budgets Elimination targets are dependent on access to and demand for hepatitis services. Adequate domestic financing is critical to maximizing access. ¤ Undertake a national investment case for hepatitis B and C to advocate for increased national budget allocation and inclusion of interventions, along with primary prevention interventions, in essential health benefit packages. ¤ Advocate for expanded international financing mechanisms for low- and middle-income countries for hepatitis commodities, especially in coinfection. ¤ Ensure national programmes pursue cost efficiencies, including integrating services, reducing costs, improving efficiencies and following price reduction strategies for hepatitis services. ¤ Where state or provincial level budget allocation is an important contributor, ensure that such funding is sufficient to meet viral hepatitis service needs for the state or province. 31 Essential hepatitis commodities Equitable and reliable access to viral hepatitis commodities is essential to support consistent and effective national action. The following are the key elements: ¤ make available low-cost quality-assured rapid diagnostic tests (RDTs) for hepatitis; ¤ consider innovative financing mechanisms to reduce the cost of molecular tests for HBV and HCV; ¤ encourage generic medicine markets, greater market transparency and pooled purchase mechanisms to reduce costs for medical products; Implement effective pricing policies for market price control Improve availability of essential medical products and reduce stock-outs Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 53 No. Areas of implementation Country actions 32 Health workforce for viral hepatitis Decentralization of hepatitis services with maintenance of quality and outcome requires a hepatitis-literate workforce. National programmes should implement various actions to this end. ¤ Actively build health-worker literacy in viral hepatitis risk factors, prevention and management and in essential hepatitis interventions. ¤ The specific focus should be on the primary health-care level with the use of mentoring, remote supervision and support from specialist services, including through virtual systems. Implement occupational health and safety programmes, including testing and routine hepatitis B vaccination of health-care workers and testing and treatment for HCV. 3.5 Strategic Direction 3: generate and use data to drive decisions for action This section describes viral hepatitis-specific actions to strengthen health information systems for better data availability, use and accountability. The actions in this section should be implemented in conjunction with the relevant integrated actions. No. Areas of implementation Country actions 33 Person-centred monitoring and information systems for viral hepatitis Economies of scale and existing infrastructure should be utilized for viral hepatitis, including national surveillance and HIV surveillance systems. Where absent, establish national baseline data for prevalence, incidence, prevention and treatment cascades. Leverage existing national population- based or targeted surveys where possible. Use existing reporting systems to capture aggregated and disaggregated data for hepatitis cascades of care by sex, socioeconomic status (where possible) and geography, made available to monitor both quality and equity and inform decision-making. Viral hepatitis information systems should be integrated with HIV/STI/ TB systems and enable data triangulation for analysis, including with vital statistics, cancer registries and immunization registries. Prepare data measurement systems to enable WHO to validate the elimination of viral hepatitis. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 54 3.6 Strategic Direction 5: foster innovations for impact This section describes viral hepatitis-specific actions to foster and disseminate innovations for accelerated impact. No. Areas of implementation Country actions 34 New diagnostics and treatment approaches Innovations are necessary to expand testing to improve the Region’s hepatitis care cascade. These may include: ¤ simple, affordable and reliable diagnostics, including point-of-care technologies to confirm the presence of viraemic hepatitis C virus infection; ¤ availability and use of RDT HCV core antigen test and RDT e-Ag for HBV where polymerase chain reaction (PCR) is not available; ¤ use of polyvalent or integrated diagnostic platforms that include hepatitis; ¤ self-testing for hepatitis C virus; ¤ implement affordable methods for staging liver disease, including bio-algorithms such as APRI or FIB-4; ¤ standardized care and treatment pathways to the minimal time and tests while increasing efficiency including the “one-stop shop” model of viral hepatitis prevention, testing, care and treatment for vulnerable populations needing comprehensive care. Source: https://www.who.int/docs/default-source/wpro---documents/wpro---pdf-infographics/ hiv/syphilis-20190320.pdf?sfvrsn=e88c0209_2

Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 57 4. HIV This chapter presents the actions for HIV as part of I-RAP (2022–2026). It builds on the successes and lessons learnt from the RAP for HIV in SE Asia (2017–2021) and details the key actions necessary for the Region to end AIDS as a public health threat by 2030 with priority targets, interventions and innovations. These actions fully align with the UNAIDS Global AIDS Strategy (2021–2026) and other related global strategies. Actions for countries in this chapter should be implemented in conjunction with and in addition to the integrated actions for countries defined in Chapter 2. 4.1 Key areas for urgent attention towards the regional elimination goal ¤ The HIV epidemic in the Region continues to predominantly affect the key populations and their partners. Hence, improving coverage of interventions among key populations, including youth, should be a key focus. ¤ A renewed focus on prevention and education for the youth is needed. ¤ EMTCT needs focus, especially following the interruption during the COVID-19 pandemic. Interventions like PrEP need to be scaled up urgently. ¤ The major causes of HIV-related deaths need to be addressed, including TB. ¤ There is a continuous need to focus on diagnosing and managing advanced HIV disease. ¤ The use of newer diagnostic innovations like HIV self-testing and newer prevention tests such as PrEP need to be scaled up urgently. ¤ Stigma and discrimination deter key populations from accessing prevention and treatment services and are still present in countries where the laws and policies institutionalize such behaviour. This needs to be addressed. ¤ Community-led service delivery is important to facilitate access for these populations. ¤ The mental health of PLHIV should be given priority. ¤ Large data gaps remain in strategic information. Further disaggregated granularity is necessary. HIV targets Table 4 presents the impact and programmatic coverage indicators and targets and policy milestones for HIV. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 58 Table 4. Impact and coverage indicators, targets and milestones for HIV, by 2025 and 2030 Indicator Baseline–2020a Targets–2025 Targets–2030 Impact indicators Number of people newly infected with HIV per year 140 000 41 000 35 000 Number of people newly infected with HIV per 1000 uninfected population per year (SDG 3.3.1) 0.05 0.04 0.025 Number of children 0–14 years of age newly infected with HIV per year 9000 3000 1500 Number of people dying from HIV/related causes per yearb (including disaggregation by HIV, cryptococcal meningitis, TB and severe bacterial infections) 94 000 32 000 30 000 Number of countries validated for the elimination of vertical (mother- to-child) transmission of HIV, hepatitis B, or syphilis 3 5 11 Coverage indicators Percentage of PLHIV who know their HIV statusc 77% 95% 95% Percentage of people who know their HIV-positive status and are accessing ARTc 78% 95% 95% Percentage of PLHIV receiving treatment, who have suppressed viral loadsc 91% 95% 95% Percentage of people at risk of HIV who use a combination prevention with a defined service package Varies by key population. It is <50% on average 95% 95% Condom/lubricant use at last sex with a client or non-regular partner Varies by key populationd 90% 90% Number of needles or syringes distributed per PWIDe – common HIV/viral hepatitis indicator 157 200 300 Percentage of PLHIV and people at risk who are linked to integrated health services, including STI and viral hepatitis Unreported 95% 95% Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 59 Milestones Stigma and discrimination – percentage of people living with viral hepatitis, HIV and STI and priority populations who experience stigma and discrimination Partially reported Less than 10% Less than 10% Laws and policies – number of countries that have punitive laws and policies Varied by population <3 <1 Gender – prevalence of recent (past 12 months) intimate partner violence among people aged 15–49 years Unreported <20% Less than 10% Integration – percentage of people living with viral hepatitis, HIV and STI linked to other integrated health services Unreported 95% 95% Advanced HIV disease – percentage of people starting ART with a CD4 count of less than 200 cells/mm3 (stage III or IV)f 30% 20% 10% Differentiated service delivery – percentage of countries that have implemented a 6-monthly refill of drugs 0 50% 80% a Latest data for end-2020. Some targets use data from 2019 because of COVID-19 related service disruptions in the data reported for 2020. b Disaggregated by disease coinfection. c Achieved in all ages, sexes and focus populations. dSW [67–83%]; MSM [57–95%]; PWID [22–66%]; TG [68–92%] in reporting countries. eAs part of a comprehensive harm reduction strategy and in line with national priorities. f So all PLHIV should receive a CD4 test result. Core regional targets and additional targets for 2025. Core regional HIV targets for 2025 ¤ Reduce new HIV infections by 2025 with a target of 41 000. ¤ Advance towards 95-95-95 targets for the Region by 2025. ¤ The combination prevention services package, including self-testing, condoms, clean needles and syringes, OST and PrEP should be made available to 95% of SWs, PWID, transgender persons and MSM by 2025 ¤ Scale up testing resources using HIV self-test, community-based services, virtual space interventions to reach first 95. ¤ Increase the percentage of PLHIV who are offered preventive therapy for TB with a target of 95%, by 2025. ¤ Increase the percentage of PLHIV and people at risk who are linked to integrated health services, including STI and viral hepatitis, with a target of 95%. ¤ Reduce the proportion of HIV diagnoses with advanced disease. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 60 4.2 Strategic Direction 1: deliver high-quality, evidence- based people-centred services This section describes HIV-specific priority actions for countries along the continuum of HIV prevention, diagnosis, care and treatment services. Country-specific strategic information on risk groups according to demographics and behaviour should inform the development of a list of priority populations for national plans. 4.2.1 Delivering the continuum of HIV services The continuum of HIV services provides an organizing framework for implementation of essential interventions that comprehensively address people’s needs relating to HIV prevention, testing, treatment and chronic care. Service access may be interrupted at each stage as people move along the continuum. Health services must be client-centred rather than service-centred and organized such that individuals can be continuously engaged in care, including through community access points where appropriate to optimize outcomes across the life course. Stigma must be actively addressed in all HIV services, including through training, community engagement and provision of peer-led services for key populations. The retention cascade should be monitored to identify areas in which programmatic improvements are needed (Fig. 15). Fig. 15. The HIV service engagement cascade 75 80 85 90 95 100 105 Reached by preven�on ac�vi�es (reaching all priority popula�ons) Diagnosed Treatment Virally supressed Pe rc en ta ge o f P LH IV The HIV service con�nuum Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 61 No. Areas of implementation Country actions 35 Comprehensive HIV prevention National programmes should make available a strategic combination of biomedical, behavioural and structural interventions. These include the following: ¤ offer PrEP as an additional prevention choice for all individuals with a self-assessed risk of acquiring HIV; ¤ offer PEP to all people who have had a significant exposure to HIV and support transition to PrEP. ¤ promote treatment as prevention and the concept of U=U; ¤ targeted prevention programmes for key populations, including MSM, transgenders, SWs and PWUD; ¤ make available and promote male and female condoms and safe injecting equipment. National programmes should make available comprehensive interventions for HIV prevention for PWUD, including stimulants. These are: ¤ condoms, lubricants and safer sex programmes; ¤ needle and syringe programmes and other commodities; ¤ evidence-based psychosocial interventions and drug dependence treatments; ¤ prevention, diagnosis and treatment of STI, hepatitis and TB; ¤ targeted information, education and communication for people who use stimulant drugs and their sexual partners; ¤ risk mitigation including legal risk mitigation, especially in countries which criminalize specific key populations to support access to services. 36 Expanded people-centred HIV testing/screening National programmes should include an optimal combination of HIV testing approaches, including through clinical settings, community- based approaches or self-testing. Specific tasks are to: ¤ expand HIV testing to meet coverage targets at national and subnational levels; ¤ engage in targeted HIV case finding among infants and children to increase HIV diagnosis coverage in these populations; ¤ expand use of point-of-care testing for HIV in all health-care contexts; ¤ offer peer-led or self-testing for key populations and for persons with a self-perceived risk of acquiring HIV; ¤ consider social network strategies to reach persons not routinely tested for HIV. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 62 No. Areas of implementation Country actions 37 Safe, effective and responsive HIV treatment and care National HIV treatment should include rapid and effective ART with support to boost adherence, optimize clinical outcomes and minimize resistance. ¤ Ensure rapid initiation (within seven days of HIV diagnosis) of HIV treatment with WHO-recommended treatment regimens for all PLHIV,4 using agents with a high barrier to resistance such as integrase inhibitors. ¤ Offer treatment through delivery models that provide people-centred care, monitoring and support for adherence and retention and re-engagement in care, with service differentiation tailored to the country context. ¤ Increase availability of viral load testing through standard means, while also including point-of-care viral load testing and laboratory-based testing for monitoring to promote optimal treatment outcomes. ¤ Expand laboratory capacity to monitor HIV drug resistance. ¤ Consider innovative solutions to address resistance including early or e-consultation referral mechanisms, e.g. clinical expert panels such as e-SACEP5 for second- and third-line treatment in India. ¤ Make available tailored adherence support to maximize retention in care, including: ¢ once a day fixed-dose WHO recommended regimens; ¢ offering patients the option of multi-month dispensing; ¢ expanding availability of long-acting injectable antiretrovirals initiated through regulatory approval mechanisms. ¤ Optimize adherence in combination with supply chain integrity to ensure uninterrupted availability of test kits, test reagents and medical products and minimize the public health impact of HIV treatment resistance. ¤ Strengthen pharmacovigilance system for patient safety monitoring. ¤ Make available interventions to trace people who have disengaged from care and support their re-engagement. 38 Reduce prevalence and impact of advanced HIV disease Late HIV diagnosis is universally associated with poorer clinical outcomes, poorer quality of life and substantially increased mortality. Late diagnoses are often made through other services such as NCD clinics. ¤ National programmes should design and offer a specific care package for advanced HIV disease including diagnostic workup, treatment and/or prophylaxis for major causes of morbidity and mortality among PLHIV such as TB and cryptococcal meningitis. ¤ Laboratory capacity for CD4 monitoring will be required as part of this package for advanced HIV dosage. 4 Noting target is 95%. 5 Driven by the COVID-19 pandemic, the e-SACEP (State AIDS Clinical Expert Panel) mechanism in targeted districts caters for e-consultations with tertiary and ART centres. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 63 No. Areas of implementation Country actions 39 Holistic care to improve quality of life in PLHIV Well-managed HIV is now a chronic infection and is associated with noncommunicable (chronic) disease, impacting quality of life over the longer term. Many populations that are affected by HIV also have high levels of mental health disorders. Disability in the context of HIV includes physical, cognitive and mental health related disability. The key areas of focus for national programmes are: ¤ screening and integrated care for mental health; ¤ the quality of life of adults and children living with HIV should be monitored and their health and well-being needs addressed holistically over their lifetime; ¤ provide rehabilitation services, including physical, cognitive and emotional services as part of comprehensive HIV services; ¤ the provision of palliative care must be included as an essential component of comprehensive clinical management for PLHIV. 40 Reduce and eliminate vertical HIV transmission ¤ Promote integrated approaches with sexual and reproductive health programmes for HIV prevention and family planning. ¤ Screen all pregnant women for HIV, syphilis and hepatitis B. Incorporate the use of multiplex point-of-care testing where possible. ¤ Link HIV and ANC programmes to ensure treatment continuity between service delivery points for preventing MTCT. ¤ Make available a package of care for HIV-exposed infants including infant testing and prophylaxis. 4.3 Strategic Direction 2: optimize systems, sectors and partnerships for impact This section describes HIV-specific priority actions to strengthen health service delivery and other health system functions including multisectoral collaboration. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 64 No. Areas of implementation Country actions 41 People centred, decentralized and integrated services Integration with primary care The goal of the SE Asia Regional Strategy for PHC 2022–2030 is to achieve UHC, health security and the health-related SDG targets by 2030 through a PHC-oriented health system. This includes actions as below. ¤ Develop a package of HIV services which can be delivered as part of primary care, including in areas of low HIV prevalence. This could include dual HIV and syphilis point-of-care testing, hepatitis B vaccination and a syndromic approach to STI treatment. ¤ Core interventions of the package include: ¢ EMTCT for HIV including universal testing, with universal treatment for HIV-infected pregnant women and their neonates, aligned with triple elimination; ¢ harm reduction (needle and syringe programme including LDSSs and OST for PWUD/PWID); ¢ HIV self-testing, peer-led partner and contact tracing and rapid HIV testing including at non-HIV services; ¢ screening and treatment for viral hepatitis and STI at HIV services; ¢ universal male and female condom access; ¢ antiretrovirals for both prevention and treatment of HIV; ¢ comprehensive single-window services for transgender persons including gender-affirming care, hormone replacement and mental health. ¤ Expand sexual health and HIV education and training of all health-care workers to ensure that all individuals who seek sexual health services can do so in an environment free from stigma and discrimination and receive high quality, acceptable care. ¤ Stigma in health-care settings and communities and self-stigma must be addressed to enable access to care in a range of settings. ¤ Peer-led services for marginalized key populations should remain an important component of HIV services. ¤ Integrated person-centred HIV care also encompasses addressing reproductive health needs including contraception and fertility. ¤ Countries should develop appropriate models for integration and linkage based on their context and health system characteristics. ¤ Provide linkages for care of people with chronic HIV to NCD services for early diagnosis, care and effective and timely management of these comorbidities. 42 HIV and TB ¤ Implement systematic screening for TB symptoms among PLHIV and provide TB preventive treatment (particularly with short regimens). ¤ Undertake, with national TB programmes, HIV testing of all people diagnosed or presumed to be having TB. ¤ Implement timely initiation of ART and WHO-recommended chemoprophylaxis for people with TB coinfection. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 65 No. Areas of implementation Country actions 43 Essential HIV health commodities ¤ Ensure equitable and reliable access to quality-assured and affordable commodities. This includes: ¢ medicines for ART including for children; ¢ PrEP and PEP; ¢ diagnostic testing supplies; ¢ other health products including male and female condoms, lubricants, commodities for voluntary medical male circumcision and needles and syringes for harm reduction and opioid substitution treatment. ¤ Expedite the availability of new products such as HIV rapid point-of- care tests, HIV self-tests and new antiretroviral drugs and long-acting preparations, where available. 4.3.1 Tuberculosis and HIV TB is the leading cause of death among PLHIV. Although the number of TB deaths among PLHIV in SE Asia has seen a 74% reduction from 76 100 in 2010 to 19 600 in 2019, less than one third of the estimated number of people coinfected with HIV and TB were reported to be receiving both HIV and TB treatment in 2019 (29). The global End TB Strategy (30) gives priority to collaborative activities to jointly address TB and HIV through integrated people-centred care. This includes systematic screening for TB symptoms among PLHIV, TB preventive treatment, HIV testing of all people diagnosed with or presumed to be having TB, timely initiation of ART for people with TB, WHO-approved chemoprophylaxis and the treatment of drug-susceptible and drug-resistant TB. The regional strategic plan towards ending TB in the WHO SE Asia Region 2021–2025 is in line with the global targets of the End TB Strategy, which calls upon Member States to achieve an 80% reduction in the TB incidence rate by 2030 (compared with the 2015 baseline), 90% reduction in TB deaths by 2030 (compared with 2015) and 100% TB-affected families to be protected from facing catastrophic costs due to disease from 2020 onwards. The Regional TB Strategy has the goal that ≥90% of PLHIV newly enrolled in care will receive treatment for latent TB. There are opportunities for programme collaboration, such as joint planning, surveillance and financing. Common approaches to address the inequalities that drive both HIV and TB are also important to prevent and manage HIV-associated TB. This includes the use of new points-of-care diagnostics and innovative treatment, e.g. newer short course therapy for TB preventive treatment (TPT). 4.4 Strategic Direction 3: generate and use data to drive decisions for action This section describes HIV-specific actions to strengthen health information systems for individual patient care and national and subnational surveillance, aiming for interoperable, interconnected, electronic real- time reporting systems. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 66 No. Areas of implementation Country actions 44 Integrated person- centred monitoring and surveillance ¤ Utilize existing infrastructure for HIV monitoring to optimize outcomes, including use of unique identifiers to allow individualized outcome analysis and management and to avoid duplicate entries for individuals. ¤ Enable confidential data sharing across health services to support patient care. ¤ Strengthening surveillance will require investments in data capacities and strengthening in-country laboratory capacity. ¤ Utilize WHO-developed tools including SCORE data collection tools (31) to build on existing national surveillance capacity. ¤ Data should be disaggregated by sex, age, socioeconomic status, geography and other relevant population characteristics to monitor equity in access and outcomes. ¤ Undertake regular population size estimates for key populations (including virtual key populations) to allow estimation of the HIV cascades of care in these groups. ¤ Consider the utilization of HIV surveillance and monitoring systems for other disease categories to drive integration, e.g. expanding STI surveillance and integrating with HIV ¤ reporting systems including integrated behavioural and biological surveys. ¤ Consider recent infection surveillance to facilitate early identification of outbreaks. ¤ Institutionalize regular systems of data quality assurance and establish M&E frameworks. ¤ Integrate data systems for HIV, STI and viral hepatitis. 4.5 Strategic Direction 5: foster innovations for impact This section describes HIV-specific actions to foster and disseminate innovations for accelerated impact. No. Areas of implementation Country action 45 New HIV diagnostics technologies and testing approaches ¤ Make available polyvalent or integrated diagnostic platforms for the combined diagnosis of HIV and comorbidities such as TB, viral hepatitis and syphilis. ¤ Offer HIV self-testing and rapid point-of-care tests in a range of settings to improve access. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 67 No. Areas of implementation Country action 46 Optimized use of antiretroviral drugs and HIV vaccines, including for prevention and cure ¤ Support research on optimal doses and formulations of emerging antiretroviral and non-antiretroviral drugs to minimize drug–drug interactions and reduce costs. ¤ Expand access to novel ARV based prevention, i.e. treatment as prevention (TasP) by offering this as an option to all affected persons. ¤ Expand access to PrEP and PEP including long-acting injectable preparations and other new technologies as they become available. ¤ Support research into improved HIV therapeutics including vaccine and cure through international collaboration. ¤ Support research on implementation technologies to facilitate adherence including web-based refills, remote testing and adherence reminders and offer the same in programmes.

© WHO SEARO/Christine McNab

Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 71 5. Sexually transmitted infections Actions for STI given in this chapter should be implemented by countries in conjunction with and in addition to the integrated actions described at Chapter 2. Key challenges and gaps identified across the Region include: ¤ national strategies oriented towards HIV, with little attention to STI control; ¤ a general heterogeneity in services available to diagnose and treat STI across countries of the Region; ¤ a lack of resources specific to STI programmes; ¤ commodity gaps including a lack of reliable supply of STI diagnostics and treatment; ¤ variable clinical service and contact tracing including guidelines, training and supervision to manage cases and contacts; ¤ inadequate surveillance systems for STI and antimicrobial resistance (AMR) monitoring (10); ¤ remaining legal and policy barriers to key populations that impede equitable access to health care, along with stigma and discrimination. 5.1 Key shifts required to strengthen STI control in the Region It is recognized that there is variability in prevalence and impact of STI across countries of the Region. There is also wide variety in the access to appropriate diagnostics laboratory services and treatment within and between countries. There has not been a RAP for STI to date and as such countries of the Region may be at different stages of implementation of actions suggested in this chapter. Key shifts to remedy this situation are enumerated below. ¤ Reposition STI control as a public health priority for the Region and advocate for resources, staffing and planning potential synergies in STI/HIV control efforts, e.g. offering STI screening/ comprehensive periodic treatment at quarterly PrEP visits. ¤ Recognize successes in the Region and leverage the considerable experience and expertise from countries such as Sri Lanka and Thailand and from key population community learning sites like Durbar Mahila Samanwaya Committee (DMSC) and Ashodaya Samithi in India. Develop a flexible toolkit of proven interventions for countries at different stages of STI control including the above. ¤ Advocate for and support progress towards STI elimination, continuing with EMTCT and preparing elimination cases for infectious syphilis, chancroid and possibly gonorrhoea, recognizing that there are strong candidate countries for each of these STI elimination targets in the Region. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 72 ¤ Address the considerable STI data gaps and limitations in most countries, advocating for and supporting basic STI surveillance components including routine reporting (syndromic/ aetiological), routine prevalence monitoring (ANC and key population syphilis screening) and leveraging regional experience and expertise including for drug resistance patterns to inform effective case management. ¤ Rapid response methods to identify and control STI outbreaks (this is particularly important as countries move towards elimination). 5.2 STI targets Tables 5 and 6 present impact and coverage targets and policy milestones for STI in the Region. Table 5. Impact and coverage indicators, targets and milestones for STI, by 2025 and 2030 Indicator Baseline – 2020a Targets – 2025 Targets – 2030 Number of new cases of four curable STI in adults (15–49 years) per year ('000) 59 677 47 742 21 273 Number of new cases of syphilis in adults (15–49 years) per year ('000) 354 283 35 Number of new cases of gonorrhoea in adults (15–49 years) per year ('000) 21 059 16 847 2106 Congenital syphilis cases per 100 000 live births per year 145 <75 <50 Percentage of girls fully vaccinated with HPV vaccine by 15 years of age 14% 50% 90% Percentage of pregnant women attending ANC who were screened for syphilis/percentage treated if positive 65%/71% >85%/>90% >95%/>95% Percentage of priority populationsb screened for syphilis/ percentage treated if positive No data/no data >80%/>90% >90%/>95% Percentage of priority populationsb screened for gonorrhoea/percentage treated if positive No data/no data >20%/>90% >90%/>95% Percentage of women screened for cervical cancer using a high-performance test by the age of 35 and again by the age of 45. Percentage having the pre-cancer treated or invasive cancer managed No data/no data >40%/> 40% >70%/>90% Number of countries reporting AMR in Neisseria gonorrhoeae to GASP 36% >60% >70% Planning: number of WHO Member States with national STI plans updated within the past 5 years 50% >70% >90% Policies: number of WHO Member States with national STI case management guidelines updated within the past 3 years 40% >70% >90% Surveillance: number of countries with strong STI surveillance systemsc No data 5 11 GASP – Gonococcal Antimicrobial Surveillance Programme a Latest data for end 2020. Some targets use data from 2019 because of COVID-19 related service disruptions in the data reported for 2020. b Priority populations are defined by individual countries. For screening include MSM, SWs and PLHIV. c A strong surveillance system for sexually transmitted infections incorporates four core competencies: case reporting; regular prevalence assessments among ANC, men and priority populations; regular annual reviews of the causation of STI syndromes and symptomatic data corrected for underreporting; and monitoring of AMR for Neisseria gonorrhoea. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 73 Table 6. Syphilis EMTCT targets (25) EMTCT impact target A case rate of CS of ≤50 per 100 000 live births EMCT process targets ¤ ANC coverage (at least one visit) of ≥95% ¤ Coverage of syphilis testing of pregnant women of ≥95% among those who attended at least one ANC visit ¤ Adequate syphilis treatment of syphilis-seropositive pregnant women of ≥95% CS – congenital syphilis 5.3 Core Regional syphilis targets and additional targets for 2025 ¤ Reduce incidence and prevalence of the four key curable STI: syphilis, gonorrhoea, chlamydia and trichomonas in line with mentioned targets ¤ Eliminate MTCT of syphilis in all countries (<50/100 000 live births) ¤ Increase HPV vaccination coverage ¤ Increase proportion of key populations receiving regular medical care including screening for syphilis and gonorrhoea and treatment if positive ¤ Increase number of Member States with STI surveillance systems ¤ Increase number of Member States with STI programmes, including M&E mechanisms. 5.4 Strategic Direction 1: deliver people-centred evidence- based services Priority populations for STI include SWs and their clients, MSM, transgender persons, young people, PLHIV and pregnant women and their exposed infants. Other groups that are especially vulnerable to STI in many settings include people who have experienced gender-based violence, indigenous peoples, children and young people living on the street, people affected by conflict and civil unrest and people with disabilities. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 74 No. Areas of implementation Country actions 47 Expand primary prevention ¤ Develop, implement and scale up effective primary prevention interventions tailored to different populations and locations, including provision of HPV vaccines and other vaccines as they become available. ¤ Develop primary prevention initiatives for key populations and implement and evaluate these in collaboration with affected populations, community groups and NGOs. ¤ Free access to condoms in a variety of settings to which key populations have access is a key intervention. ¤ Take prevention initiatives for STI integrated with HIV, PrEP and hepatitis prevention through HBV vaccination for key populations. ¤ Build STI literacy across populations to seek care for symptoms of STI and prevent reinfection. ¤ A range of health promotion initiatives for key populations and the general population should be used, including: ¢ mass media campaigns ¢ education in schools ¢ targeted health promotion activities conducted by community groups. ¤ Information and education campaigns should adopt positive approaches to promoting sexual health, normalize discussion of sexual health and teach individuals to recognize symptoms of STI. ¤ Effective vaccines exist for preventing HPV infections, but coverage is low. Wider provision of these vaccines will drastically reduce new cases of cervical, penile and anal cancers. Address barriers to uptake and vaccine hesitancy. 48 An effective STI service continuum Provide a comprehensive continuum of STI services based on the needs of populations (Fig. 16). ¤ Each country needs to define a package of essential STI interventions along the service continuum aligned with UHC benefit packages and linked to PHC. ¤ All services must be non-stigmatizing, rights-based, quality services. ¤ Health systems must identify and remove physical and information barriers that hinder vulnerable populations from accessing STI information and services. ¤ Self-care strategies, including self-collection of specimens and telemedicine, can reduce barriers to accessing STI services and should be made available where possible. ¤ Services should utilize evidence-based interventions including same-day treatment, evidence-based guidelines and partner notification. ¤ STI services should be accessible in settings where individuals are more likely to seek care such as at PHCs and community health services. Testing and diagnosis ¤ Develop national STI policies and guidelines, including screening strategies based on available epidemiological data, considering the following: ¢ all individuals tested for HIV should also be tested for syphilis; ¢ as technology becomes available, expand screening opportunities for Chlamydia trachomatis and Neisseria gonorrhoeae with next generation lower cost point-of-care diagnostic tests; Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 75 No. Areas of implementation Country actions 48 An effective STI service continuum (contd.) ¢ laboratory capacity should be developed to improve diagnosis of symptomatic and asymptomatic STI. Quality assurance systems should be established. Treatment ¤ Evidence-based national guidelines on managing STI should be developed based on WHO guidelines (32). ¤ Guidelines should include consideration of asymptomatic screening and/ or treatment based on risk in line with WHO recommendations. ¤ Same-day treatment for curable STI should be made available. ¤ Hesitancy to IM benzathine penicillin for syphilis should be addressed. ¤ Retention and referral mechanisms for those needing ongoing care should be established. Partner notification and contact tracing ¤ Strategies for establishing voluntary partner notification and treatment should be developed and implemented, ensuring that services are accessible and confidential. Such strategies are crucial to avert further transmission of STI and reinfection. ¤ Evidence-based strategies, such as expedited partner treatment and voluntary provider-assisted referral of sexual partners could be adapted to local contexts. ¤ Social network-based approaches developed for HIV testing could be adapted to reach and offer partner management services for the sexual partners of those diagnosed with other STI. ¤ Innovations in contact tracing for COVID-19 should be explored, including through the use of digital platforms to support partner testing. The care cascade ¤ The care cascade should be monitored to determine where loss to follow up is occurring. This needs to be addressed. ¤ Services were disrupted substantially during the COVID-19 pandemic, and some are yet to reach pre-pandemic levels of functioning. Efforts to improve resilience of services and regular monitoring will be required. Fig. 16: The STI reinfection service process Preven�on Diagnosis Cure and/or chronic care Treatment Screening for HIV and viral hepa��s Partner no�fica�on and treatment Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 76 No. Areas of implementation Country actions 49 Reduce and eliminate vertical transmission ¤ Several STI, including HIV, syphilis, gonorrhoea, chlamydia, herpes simplex virus, and HTLV-1 can be transmitted vertically. ¤ National programmes should reduce vertical transmission of STI with a focus on triple elimination, through: ¢ implementation of STI services at the PHC level, taking a syndromic approach to diagnosis and treatment, with secondary and tertiary facilities providing diagnostics- driven treatment; ¢ screening for maternal syphilis early in pregnancy, using recommended point-of-care tests in ANC and prompt treatment of seropositive women (at least four weeks prior to delivery with intramuscular benzathine penicillin G, a long-acting penicillin). This cures syphilis in both mother and foetus and prevents congenital syphilis (25); ¢ for syphilis, screening and treatment should ideally be in the first ANC visit; ¢ follow up infants born to untreated mothers with syphilis, or mothers not treated with benzathine penicillin G; ¢ coverage of prevention of mother-to-child transmission (PMTCT) programmes should be prioritized to achieve the objectives of triple elimination of MTCT of HIV, syphilis and hepatitis B; ¢ provide timely identification and treatment of pregnant women, their sexual partners and their exposed infants and young children (25); ¢ undertake primary prevention of new infections in women and girls of reproductive age and their sexual partners. ¤ Other actions to be considered after triple elimination interventions are: ¢ administer routine prophylaxis for ophthalmia neonatorum where prevalence of chlamydia and gonorrhoea is high and mothers are not routinely screened; ¢ implement suppressive herpes simplex virus therapy for women with suspected primary genital herpes during the last trimester of pregnancy. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 77 5.5 Strategic Direction 2: optimize systems, sectors and partnerships No. Areas of implementation Country actions 50 People-centred and decentralized services (contd.) Provide people-centred, decentralized and integrated STI services and improve coverage of services. Integration into primary health care ¤ Integrating STI services into PHC is essential. This is in line with the goal of the SE Asia Regional Strategy for PHC 2022–2030 to achieve UHC, health security and the health-related SDG targets by 2030 through a PHC-oriented health system (33). ¤ Develop a package of services which can be delivered in primary care, including in areas of low STI prevalence. This could include dual HIV and syphilis point-of-care testing, hepatitis B vaccination and a syndromic approach to STI treatment. ¤ Develop clear pathways and indications for primary-care referral to secondary or tertiary facilities where further services such as chlamydia and gonorrhoea testing may be available. ¤ Expand sexual health education and training of all health-care workers to ensure that all individuals who seek sexual health services can do so in an environment free from stigma and discrimination and receive high quality, acceptable care. ¤ Providing non-stigmatizing, rights-based, high quality STI services in a range of settings including primary care will improve coverage. Other areas for integration ¤ Countries should develop appropriate models for integration and linkage based on their context and health system characteristics. The HIV service delivery model could be adapted for integration and decentralization of STI services. ¤ Linkages, collaboration and integration between STI services and other health services may include: ¢ adolescent health services and school health education services ¢ family planning ¢ maternal and neonatal care ¢ immunization ¢ NCDs, mental health, and health promotion ¢ strong referral mechanisms with cancer services. ¤ Encourage and work with the private sector, nongovernmental organizations (NGOs) and community groups to develop innovative approaches and collaborations to scale up the prevention initiatives, access to vaccines, laboratory services, treatment and care. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 78 No. Areas of implementation Country actions 50 People-centred and decentralized services (contd.) Community-centred care for key populations ¤ Develop service delivery models to make high-quality, non- stigmatizing STI services accessible and acceptable to priority populations. ¤ Develop decentralized and differentiated service delivery models of ensuring equity in service access for key populations and reaching those who are not yet linked to services, such as in rural areas. ¤ Integration of service delivery for key populations should involve representatives of affected communities and be separately addressed with a clear definition of coverage and impact targets. ¤ Services should be delivered within/alongside comprehensive single window services for transgender persons. 51 Mobilize funding Mobilize additional funding to support the expansion of STI prevention and treatment services. ¤ Political support and effective advocacy are needed, with the involvement of key populations. ¤ Increase awareness of the public health impact of STI and secure adequate funding to address this impact. ¤ STI programmes need to be costed and included in the NSP for hepatitis, HIV and STI. ¤ STI services need to be included in the PHC service package funded by governments and health insurance. ¤ Key medications need to be included in essential medicines lists. 52 Equitable and reliable STI commodities Ensure equitable and reliable access to high-quality and affordable medicines, diagnostics, vaccines, condoms and other health products for STI. ¤ Leverage integrated procurement and supply chain mechanisms by: ¢ pooled procurement of essential STI medicines including benzathine penicillin, diagnostics and reagents; ¢ optimization of technical resources, training and capacity enhancement across HIV, hepatitis and STI. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 79 5.6 Strategic Direction 3: generate and use data to drive decisions for action No. Areas of implementation Country actions 53 Strengthen STI laboratory capacity Enhance laboratory capacity to improve case management and surveillance of STI. ¤ Improved screening for asymptomatic infections is needed to monitor and control disease, as STI are often asymptomatic. ¤ While syndromic management strategies are highly effective, targeted antibiotic treatment will become more important in an era of accelerating AMR. ¤ Develop country-specific, risk-based screening strategies targeted at key populations and vulnerable communities, considering laboratory requirements for the different health-care levels, resourcing, staff training and commodities. ¤ Syphilis screening should be prioritized. Gonorrhoea and chlamydia screening should be undertaken where feasible. ¤ Laboratory capacity should be expanded at all levels including laboratory workforce capacity through training and adoption of new technologies 54 AMR monitoring There is widespread resistance to most medicines used to treat gonorrhoea in many parts of the world. Other STI pathogens with potential AMR include Mycoplasma genitalium and Trichomonas vaginalis. National programmes should monitor the patterns of AMR to inform treatment recommendations and policies. ¤ Strengthen and expand surveillance and monitoring of treatment failures and participate in building regional networks of laboratories to perform gonococcal culture and antimicrobial susceptibility testing. ¤ Use data obtained through antimicrobial surveillance to regularly update national treatment guidelines and policies. ¤ Strengthen national drug regulations and prescription policies and increase awareness of the correct and standardized use of antimicrobial agents among health-care providers and consumers, especially in priority populations. 55 STI surveillance Strengthen STI surveillance and monitoring. ¤ There are four core components of STI surveillance: case reporting, prevalence assessments, assessment of the aetiology of STI syndromes and monitoring of AMR. ¤ In many countries, STI surveillance systems rely on syndromic case reporting. Strengthening surveillance will help ensure that countries have the relevant data to inform decision-making. ¤ Combinations of syndromic and aetiological reporting have been used in several countries and could be adapted elsewhere. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 80 No. Areas of implementation Country actions ¤ STI surveillance systems should be developed by expanding on and integrating with HIV reporting systems including integrated behavioural and biological surveys (IBBS). ¤ Strengthening surveillance will require investments in data capacity and strengthening in-country laboratory capacity. ¤ In countries where private sector laboratories, pharmacies and clinicians provide a substantial proportion of STI services, it is important to promote regular reporting from these providers. ¤ Data should be disaggregated by sex, age, socioeconomic status, geography and other relevant population characteristics in alignment with national priorities to monitor equity in access and outcomes. ¤ Reporting systems should also collect data on other health outcomes related to STI such as congenital syphilis. 5.7 Strategic Direction 5: foster innovations for impact This section describes STI-specific actions required to foster and disseminate innovations for accelerated impact. The actions in this section should be implemented in conjunction with the relevant integrated actions. While countries may be able to support all of the below, collaboration with partners within and outside of the Region will allow early exposure and access to new innovations. No. Areas of implementation Country actions 56 Innovations in prevention Identify, evaluate and scale up best practices in preventing STI. ¤ Advances in health promotion and care such as HIV prevention services and dissemination of health information using social media should be assessed for their relevance to STI and scaled up as appropriate. 57 Innovations in diagnosis and treatment Monitor development of and adopt innovations in STI diagnostics and treatment to address local challenges. ¤ Consider implementation of self-sampling, which has been shown to increase testing uptake. This should be considered where possible for diagnostic testing. ¤ Use low-cost, rapid point-of-care diagnostic tests for asymptomatic screening where access to diagnostic laboratory facilities is limited, as well as for new point-of-care and home-based diagnostics. ¤ Support rapid multiplex diagnostic platform development. ¤ increase access to molecular diagnostic tests to identify and characterize AMR.

Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 83 6. Implementing the Integrated Regional Action Plan Effective implementation of the I-RAP for viral hepatitis, HIV and STI requires strong leadership, partnerships, solidarity and accountability, including multisectoral action through a whole-of-government and whole-of-society “health in all policies” approach. This chapter presents the key operational considerations for implementation of the Action Plan. 6.1 Political advocacy and commitment Political commitment is of critical importance for effective implementation of the I-RAP. At the national level, this means country ownership on the nature and extent of the problem and the programmatic solutions required to address viral hepatitis, HIV and STI. At the regional level, the Action Plan will bridge the gap between the 2021 and 2030 SDGs. Each epidemic requires strengthened political commitment and a renewed strategic focus to guide the final push to reach the SDGs. This should be reflected in active leadership of the political executive in formulation of policies, NSPs and implementation strategies and providing financial support at the national and subnational levels. Apart from the political executive, the active participation of affected persons’ representatives at the national and subnational levels will be critical. It will seek to preserve an individualized approach to each disease area while also emphasizing important synergies to be found in combating viral hepatitis, HIV and STI collectively to achieve elimination. 6.2 Governance supporting the integrated model of service delivery Integrated regional and national action to address viral hepatitis, HIV and STI is dependent on strong governance at the national, provincial and local levels. National task forces responsible for the development and implementation of integrated national action plans must ensure that integration promotes impact, especially for viral hepatitis and STI programmes, which have traditionally attracted less attention and funding. Integration must be defined so that the concept is similarly understood across the health sector and by partners. The governance of integrated national action should fall under the broader UHC agenda, including through PHC platforms. This includes UHC for key populations. Integration should encompass the national and subnational policy level, the service level and the community impact. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 84 Triple elimination of vertical transmission of HIV, syphilis and hepatitis B infection as detailed in Chapter 2 is a strong example of integration, possessing policy, service impact and M&E with an associated validation mechanism. No. Areas of implementation Country actions 58 Effective and inclusive governance Political commitment to national governance structures and costed strategic plans are necessary to guide integrated national responses to viral hepatitis, HIV and STI. ¤ Encourage national approaches to governance through the establishment and maintenance of national task forces for integrating viral hepatitis, HIV and STI action, implying collaboration across sectors and stakeholders including state or provincial governments, diverse CSOs, the private sector and communities, in a whole-of- government and whole-of-society approach. ¤ Conduct structural integration of Ministry of Health organograms on viral hepatitis, HIV and STI, with inclusion of key populations as a focus across all three disease areas. ¤ Ensure meaningful engagement of communities and civil society including all key populations in national policy formulation and implementation, promoting synergies with broader health governance structures and plans. ¤ Provide leadership that is representative across the health system and specifically in HIV, hepatitis and STI to include women and people from affected communities. The HIV and STI programmes are integrated in a number of countries as most of the populations vulnerable to these infections are common. Almost 90% of new infections of HIV in the Asia–Pacific are among key populations and their partners. It is therefore relatively easier to carry on horizontal integration from the top level of governance to field service delivery . In the case of viral hepatitis, programmes are designed and implemented through the PHC system and national health missions as a part of the general health system. It is noticed that in this process, the genuine needs of key populations get affected, as many of them do not have access to health system- based services such as testing, treatment, vaccination, etc. The level of involvement differs even within hepatitis between hepatitis B and C. In some of the SE Asian countries, hepatitis C treatment is available as a part of health care or national programmes but not for hepatitis B. While attempting an integrated model of governance, it is therefore important to build in adequate flexibility for countries to adopt a model suitable to their needs that fits into their sociopolitical context. The answer lies in adopting a client-centred approach rather than a disease-centred one for integration. While hepatitis B and C programmes for general populations can continue to be delivered through the general health-care system, these services for key populations need to be organized with strong community participation, integrating these with HIV and STI services. Keeping these requirements in mind, the following structures of governance are suggested for countries to adopt based on their needs. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 85 Total integration (for smaller countries) The three programmes should be brought under a single senior level functionary as Director of hepatitis, HIV and STI programmes. The three programme lines can be managed through senior level technical deputies under the director. This arrangement can be replicated at the provincial/district level as well. Budgets for the three programmes should be gradually brought under a single budget line. This could be an evolving process stretched over a year or two. Fund flow to the implementation level should take place through a single budgetary channel. At the field level, the technical staff working on the three programmes should be retrained and redeployed as composite teams, sharing accommodation and testing services and dispensation of medicines. Their salary levels should be redefined to avoid frustration and demotivation due to redeployment. This model works out well for smaller countries with a limited number of technical functionaries and technical service facilities at the field level. Running parallel line programmes for all the three diseases will not be cost effective in such countries. Partial integration In the partial integration model, the political decision to bring the three disease control programmes under a single umbrella of governance would still be necessary, both at the federal and provincial levels. At the senior management level, a senior functionary in the Health Ministry should be designated as the Director General (DG) of the three programmes. The DG should act as the chief coordinating agency for the integrated programme with the assistance of three senior-level functionaries as the directors for each of the three programmes. For the hepatitis programme, a separate functionary should look after linkages to the national health mission and health systems for programmes dealing with general populations such as vaccination of children, testing and treatment at the PHC level, blood safety, infection control, etc. For key populations, such services should be coordinated by the second-level functionaries who will ensure involvement of communities of key populations through community-based programmes and also establish linkages with the PHC for providing hepatitis related services (Fig. 17). Fig. 17. Example organogram for ministries of health implementing Integrated viral hepatitis, HIV and STI programmes, including focused actions to address these among key populations Director General (Hep, HIV, STI) Coordinating role for integrated response for key populations Director (HIV) Deputy Director (General interventions) Deputy Director (Key populations) Deputy Director (General interventions) Deputy Director (Key populations) Deputy Director (General interventions) Deputy Director (Key populations) Director (HEP) Director (STI) Director (Key populations) Director (Operations & Finance) Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 86 A similar pattern should be replicated at the provincial level. In countries like India where autonomous state AIDS control societies are functioning for HIV and STI programmes, a separate functionary for hepatitis should be added to the team to service the needs of key populations and establish linkages with state health systems and the PHC system. General population services for hepatitis should continue to be delivered through the health system. At the district level, the district medical/health officer responsible for disease control should coordinate the activities of the field level functionaries of all the three programmes through a reporting system established under the integrated programme. A district-level action plan should be prepared to look at the technical needs of the integrated programme and to retrain and redeploy the technical staff. 6.3 Active participation of communities of key populations in delivery of services Addressing viral hepatitis, HIV and STI in key populations in the SE Asia Region is critical to attaining the elimination goals of 2030, particularly regarding the incidence of these infectious diseases. This has been elaborated under shared actions (Chapter 2) and in individual disease chapters. In addition, the following actions are warranted to strengthen community involvement in the response. No. Areas of implementation Country actions 60 Active participation by key populations ¤ National actions should include clear guidance on community system strengthening and the differences between community-led, community-based and community-friendly approaches. ¤ Social contracting of CBOs and NGOs for delivery of prevention and treatment services should be actively pursued by respective countries. ¤ The COVID-19 context has impacted programmes in all countries but has also accelerated the use of various innovative approaches to simplify service delivery and meet the needs of people in the context of the pandemic, including with extensive engagement of all communities. These should be effectively pursued further even in the post-pandemic period. 6.4 Strategic information – integrated data systems Strategic information should be positioned as an important cross-cutting area for the three diseases. There is a need to strengthen surveillance and M&E systems for all disease areas and to promote digital systems and data analysis and use at the central and local levels. Drawing on three generations of HIV surveillance, there is a need to strive towards integrated disease surveillance for viral hepatitis, HIV and STI, with person-centred monitoring supported by a digitally-enabled M&E framework through open source platforms, where possible. The general principles for strategic information across viral hepatitis, HIV and STI within the I-RAP are: ¤ leverage existing HIV and integrated surveillance systems to include viral hepatitis and STI; ¤ identify common metrics and indicators that are feasible to collect and utilize; Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 87 ¤ strengthen overall health information and surveillance systems to support integration at national and subnational levels; ¤ improve reporting on all three disease areas, including strengthening local data availability and granularity by population and location. Strategic Direction 3 details shared actions and actions by disease category across this document. 6.5 Optimization of technical resources, training and capacity enhancement Technical and equipment resources available for the three diseases can be optimally used for the integrated delivery of services. Capacity enhancement of technical personnel should be implemented in a phased manner to enable the health workforce to manage testing, treatment and other services in an integrated model. 6.6 Integration and strengthening of laboratory services Integration of laboratory services for viral hepatitis, HIV and STI should occur through the effective and efficient use of existing infrastructure. Integration of laboratory services includes the utilization of multiplex and traditional testing modes, both rapid and platform based. It includes the integration of test reporting, reporting of tests to central registries which are themselves integrated and the use of unique identifiers to prevent duplication and allow integration with and linkages to existing reporting systems. This includes integrating with or linking to other disease reporting and surveillance systems to ensure data linkage and optimize patient care while at the same time providing informed health and disease surveillance. 6.7 Procurement and logistics Economies of scale and resultant price reductions can be secured by pooled procurement of essential medicines, diagnostics and reagents. Countries are encouraged to pool procurement, at least at the subnational level and ideally at the national level and consider exploration of supranational pooled procurement mechanisms. 6.8 Innovations and how they help in strengthening the regional response Countries are encouraged to take an evidence-based approach to the adoption of new technologies, including ensuring accelerated regulatory approval pathways are in place to expedite access to affected populations Technological solutions to improving access including developments during the COVID-19 pandemic should be utilized to optimize the effective rollout of key interventions and reduce the cost- of-service delivery. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 88 6.9 Risk mitigation strategies for implementation of the Integrated Regional Action Plan The success of the I-RAP depends to a large extent on the extent of political commitment and ownership of governments in the Region to achieve the goals set out in the Plan. Competing demands and priorities (such as those witnessed during the COVID-19 emergency) from other health and developmental issues could continue to divert the attention of the political and administrative leadership away from an organized response to the three diseases. Integration of these, and the new I-RAP must also focus on overcoming challenges. This can pertain to general issues such as the need for adequate funding, or overcoming specific programme challenges, e.g. the availability and maintenance of cold-chain infrastructure. Risk mitigation for the I-RAP will be supported by WHO and will include a risk analysis outlining various threats to the realization of the Action Plan targets. These may include: ¤ lack of political support for the integrated strategy ¤ lack of ownership for the integration model at the implementation level – turf issues with existing line managers ¤ withdrawing of international funding (GF and PEPFAR for HIV) ¤ continuing criminalization and stigmatization of key populations ¤ natural and public health emergencies engaging policy-makers’ attention. © W HO Ba ng lad es h/ Ca tal in Be rca ru

Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 91 7. Monitoring and evaluation Currently, viral hepatitis, HIV and STI have separate M&E frameworks. In an integrated model, a national unified M&E framework should be developed and operationalized at both the national and provincial levels, using packages such as DHIS2. This M&E framework should follow recommended guidelines by WHO and other technical agencies, including preparing monitoring systems and measuring tools required to support progress towards elimination and its validation. A position of Director (M&E) can function under the overall direction of the Director General of the integrated programme to coordinate the monitoring functions across all the three programmes (see organogram at Fig. 17). At the regional level, data collection and analysis efforts will be aligned with the Global AIDS Monitoring process led by UNAIDS and partner processes and the Global Hepatitis Reporting System. In all monitoring and reporting activities, WHO will ensure that data are sufficiently disaggregated by sex, age and other population characteristics to track inequalities, identify gaps and give priority to efforts to reach the populations that are being most left behind. Progress reports will be made to the Regional Committee for SE Asia in 2024 (mid-term review) and a final report following the completion of the plan will be shared in 2026. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 92 Towards an integrated DHIS-2-based system for HIV, hepatitis B and C monitoring and reporting in Bhutan Until 2019, Bhutan relied on paper-based recording and reporting for HIV. As there was no well-defined, structured reporting for hepatitis, monitoring individual patient data by health-care providers at the local level and the aggregate data by public health programme officials at the national level were challenging. As a way forward from the WHO regional workshop on the development of costed action plans for viral hepatitis in South-East Asia Region in August 2019, Bhutan decided to have an integrated reporting and monitoring mechanism for HIV and hepatitis using the DHIS-2 platform. Bhutan carried out an extensive review of the current recording and reporting system of HIV and heaptitis and revised all the necessary formats needed for the development of the integrated DHIS-2 system. Accordingly, with the financial and technical support of WHO Regional Office, the country was able to develop a comprehensive integrated DHIS-2 system in 2021. The integrated DHIS-2 system encompasses HIV prevention, testing, treatment and case-based surveillance to carry out a detailed risk assessment of the diagnosed HIV cases. Similarly, for hepatitis, the integrated DHIS-2 system includes a DHIS-2 tracker for registering and maintaining individual patient data and its monitoring over a period of time by health-care providers. As a part of the rollout, the country has trained all the end users on the new integrated DHIS-2 system and entered the data for the last three years retrospectively to set the baseline information into the new system. This will help the country in generating the required strategic information on a timely basis to improve the overall programme planning towards ending the epidemics of AIDS and viral hepatitis by 2030. Photo Credit: Ministry of Health, Government of Bhutan

Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 95 8. WHO Actions to keep the Integrated Regional Action Plan on track WHO will play a key role both at regional and national levels in closely monitoring progress across all the three programmes and advocacy and technical support to the national programme directors. The Regional Office has to work closely with WHO headquarters to ensure that regional action is fully aligned with the GHSS for HIV, viral hepatitis and STI for the period 2022–2030, including those systems supporting the measuring of progress towards the elimination goal. WHO will support all forms of partnership across the Region to maximize synergies and collective momentum to support full implementation of the I-RAP. WHO will implement the actions as listed below in support of the country actions outlined in respective chapters. No. Areas of implementation WHO Actions 1 Integration of viral hepatitis, HIV and STI At the regional and country levels, WHO will support full integration of efforts to address viral hepatitis, HIV and STI through: ¤ leadership ¤ partnership ¤ driving awareness ¤ boosting effectiveness ¤ maintenance of norms and standards ¤ direct technical assistance ¤ supporting and driving innovation through partnerships ¤ supporting countries in their efforts to measure progress towards ultimate elimination. WHO will define the key elements of integration at the political level and within health systems and work to obtain country level buy-in, in conjunction with other stakeholders. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 96 2 Leadership and partnership WHO will provide regional leadership across viral hepatitis, HIV and STI by: ¤ continuing to working closely with Member States and programmes; ¤ conducting advocacy for adequate and sustained funding in the international and domestic space through convening of funding agencies to leverage financing; ¤ supporting dedicated expertise and capacity on viral hepatitis, HIV and STI at the regional and country offices to ensure that support is provided in and for the countries with the highest disease burden; ¤ lead advocacy efforts on the need to address the disease burden in key populations and those disproportionally affected. 3 Advocacy and awareness WHO will strongly advocate for integrated action and building of awareness to address viral hepatitis, HIV and STI in the Region through all its activities including: ¤ driving thematic development and partnership for World Hepatitis Day and World AIDS Day to raise awareness in the affected and general communities; ¤ developing communications toolkits and providing guidance; ¤ partnering with the World Hepatitis Alliance and other agencies to pool messaging resources and maximise reach; ¤ working with partners in strong advocacy to convince governments that legal regulatory reforms are essential for the achievement of elimination; ¤ partnering with civil society and community organizations and other stakeholders to eliminate the stigma and discrimination associated with viral hepatitis, HIV and STI in the Region. 4 Norms and standards Through collaboration with WHO headquarters and country offices, the WHO Regional Office for SE Asia will: ¤ contribute to the development of evidence-based normative guidance and other relevant tools and service delivery approaches for viral hepatitis, HIV and STI and aid their dissemination to countries in the Region; ¤ support countries to align their national guidance in viral hepatitis, HIV and STI with recommended WHO norms and standards; ¤ support countries to develop tools and systems for measuring progress towards the ultimate validation of the elimination of viral hepatitis, HIV and STI in accordance with global 2030 goals; ¤ support the development of regional laboratory networks and standards to support quality management systems for laboratories. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 97 5 Innovation WHO will engage at the highest levels with partners including research institutes to ensure that the Region has access to the most recent innovations in viral hepatitis, HIV and STI. This includes but is not limited to the following: ¤ innovations in service delivery, including the use of new digital technologies; ¤ innovations in testing, including new rapid tests and other means to improve access to screening, especially among key populations; ¤ innovations in treatment including new formulations for hepatitis antivirals, HIV antiretrovirals and the deployment in innovative ways newer PrEP products; ¤ supporting efforts to ensure that all new innovations are adapted and implemented with a people-centred approach; ¤ supporting the engagement of civil society and communities in the adoption of any innovation. 6 Technical support WHO will continue to provide technical support to Member States in SE Asia for adoption, adaption and implementation of the I-RAP at the country level by the following measures: ¤ support tailored technical assistance to individual countries to promote equity and sustained integrated action across viral hepatitis, HIV and STI; ¤ Identify key gaps in research and support collaboration across the Region; ¤ work within WHO to support inter-programmatic collaboration for countries and other UN agencies working on immunization and combating of NCDs; ¤ support national programmes to strengthen regulatory and procurement mechanisms to support reductions in cost and maintenance of product quality, including through the WHO prequalification mechanism. 7 Monitoring, reporting and validation of progress WHO Regional Office for SE Asia will use global standards for regional adoption for collecting, analysing and using health data related to viral hepatitis, HIV and STI and support countries to build the capacity of national health data platforms to measure progress. ¤ Support the standardized assessment on the situation and response to viral hepatitis, HIV and STI including the development of national investment cases and other means of assessing the population-level, epidemiological and economic impact of national responses. ¤ Work with countries to prepare the tools necessary to measure progress in preparation for the validation of the elimination of viral hepatitis, HIV and STI by 2030. ¤ Support monitoring of progress to obtain domestic funding for an integrated response to viral hepatitis, HIV and STI. WHO Regional Office for SE Asia, in close collaboration with Member States, will report to the Regional Committee regarding progress in implementing the I-RAP in 2024 and 2026.

Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 101 9. Financing of the Regional Action Plan For a sustainable response, the I-RAP must be fully funded as part of the broader efforts to increase overall investments in health at the national level. Country responses to viral hepatitis, HIV and STI face different financing challenges, which national financing systems must address. WHO Regional Office for SE Asia supports countries to achieve continued and predictable funding, reduction of catastrophic expenditures on health and affordable access to health commodities. The following costings have been drawn from an analysis of costs of implementing the Global Health Sector Strategies on viral hepatitis, HIV and STI (2022–2030) (1). These estimates are developed through aggregated costs associated with implementation of the interventions to achieve agreed global elimination program and impact targets. These estimates provide some indication of the finance resources required for implementation of the I-RAP, consistent with the GHSS, over the coming years. These estimates are not economic impact analyses using mathematical modelling, and should not be interpreted as such. 9.1 HIV WHO developed HIV costing based on the UNAIDS Global AIDS Strategy (2021–2026) unit costs, national population size estimates and UNAIDS Global AIDS Monitoring System findings. Most unit costs are assumed to remain constant from 2021 to 2030. However, ART costs are dynamic and are likely to continue changing in the next few years. For the countries of the Region, estimated annual resource needs are projected as US$ 4.1 billion by 2025. Of this, 44% is estimated for prevention programmes and 25% for testing and treatment programmes. (Source: UNAIDS HIV Financial dashboard December 2021.) Table 7 gives the predictive costs for various key populations for the Region under various expenditure heads. Table 7. HIV estimated unit costs by service for WHO SE Asia Region (in million US$) Key population Expenditure 2022 2023 2024 2025 2026 2027 2028 2029 2030 Sex workers Services 77 89 102 114 115 115 115 116 116 PrEP 4 6 8 10 10 10 10 10 10 GBMSM Services 159 186 215 243 244 244 245 246 247 PrEP 88 132 177 222 223 224 225 226 227 Transgender people Services 128 145 162 180 181 181 182 183 184 PrEP 21 31 42 53 54 5 23 54 26 Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 102 Key population Expenditure 2022 2023 2024 2025 2026 2027 2028 2029 2030 PWID Outreach/ peer education 115 132 150 168 169 169 170 171 172 PrEP 10 14 20 25 25 25 25 25 5 NSEP 82 83 84 85 85 86 86 86 87 OST 209 241 274 307 309 310 312 313 315 Prisoners and others in confined settings Condoms 0 0 0 1 1 1 1 1 1 NSEP 33 47 62 76 76 76 77 77 77 Adults (15+) Condoms 236 244 253 261 263 265 266 268 270 PLHIV Adult ART SD/ labs 238 259 280 299 298 296 295 293 291 Adult ARVs 584 567 541 508 505 502 498 495 492 Paed ART SD 5 5 5 5 5 4 4 3 3 Paed ARVs 27 27 27 27 24 22 19 17 15 Pregnant women PMTCT 7 8 9 10 10 9 9 8 8 Testing 151 163 176 189 2 2 2 2 2 Societal enablers 273 289 310 333 328 338 345 350 352 Above site level 394 433 472 512 484 478 482 488 478 Programme management 305 335 365 396 374 369 373 377 370 Total health sector RNM 3146 3440 3734 4024 3782 3732 3763 3809 3745 NSEP – Needle Syringe Exchange Programme; GBMSM – gay, bisexual and other men who have sex with men; ARV – antiretroviral; SD – standard deviation; RNM – resource needs model Costs for programme management and above site-level costs include functions such as surveillance, information management, human resources, laboratory systems strengthening, procurement and supply chain management, law and policy. Table 8 gives the predictive overall financial needs by country and year. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 103 Ta bl e 8 . O ve ra ll e sti m ate d re so ur ce ne ed s b y c ou nt ry pe r y ea r f or H IV (in U S d oll ar s) Co un try 20 22 20 23 20 24 20 25 20 26 20 27 20 28 20 29 20 30 Ind ia 1 80 8 61 3 12 0 1 98 6 55 5 91 4 2 17 2 58 5 93 4 2 36 6 31 7 20 9 2 21 3 87 4 73 2 2 19 3 20 0 51 8 2 22 9 32 8 17 1 2 27 0 35 4 96 5 2 20 2 64 4 03 3 Ind on es ia 58 9 15 4 27 8 6 91 7 69 4 30 79 3 15 8 15 7 89 1 42 9 81 4 85 2 27 9 10 7 84 9 29 5 34 9 85 3 73 1 83 0 86 5 90 2 63 4 88 4 05 4 64 0 Th ail an d 46 7 43 5 20 0 47 3 65 5 57 5 48 0 37 0 75 4 48 7 40 9 99 2 46 2 31 7 20 9 45 4 72 5 29 9 45 0 92 8 17 1 44 7 34 0 92 4 44 1 89 0 05 5 M ya nm ar 13 1 07 2 28 4 13 2 52 6 95 8 13 4 80 7 44 3 13 6 93 2 12 0 13 8 19 0 39 6 13 9 69 2 45 4 14 1 93 7 66 7 14 2 18 0 13 0 14 1 34 8 34 0 Ba ng lad es h 93 1 37 6 45 10 6 52 8 00 1 12 2 23 2 54 3 13 9 63 9 60 6 14 3 66 2 11 3 14 7 41 7 91 4 14 9 73 6 08 2 15 0 85 2 58 3 15 1 84 6 77 7 De m oc ra tic Pe op le ’s Re pu bli c o f Ko re a 45 5 64 0 02 48 5 92 0 68 51 5 11 7 84 54 4 22 3 48 53 7 36 0 27 53 4 23 9 60 53 7 86 8 05 54 1 46 8 91 54 9 22 5 06 Sr i L an ka 37 7 91 2 04 42 5 14 7 11 47 5 71 9 00 52 9 24 0 09 52 6 40 0 20 53 0 26 4 37 53 2 94 6 81 53 2 16 8 16 53 2 32 0 56 Ne pa l 40 1 82 6 07 42 7 38 0 86 45 4 17 6 89 48 3 74 0 64 48 2 65 3 55 48 4 93 4 72 49 4 22 2 58 49 9 82 5 84 50 0 52 0 82 Tim or - Le st e 4 59 2 78 1 4 82 6 96 3 5 04 0 40 0 5 26 2 63 1 5 22 9 14 4 5 32 2 66 8 5 41 0 12 6 5 49 0 41 2 5 56 3 13 7 Bh ut an 4 45 6 97 9 4 86 2 41 7 5 33 9 70 9 5 84 9 02 4 4 89 4 65 9 4 92 3 21 2 4 94 9 39 4 4 96 3 55 5 4 98 5 33 1 M ald ive s 3 07 0 14 3 3 0 78 38 7 3 15 8 87 8 3 26 8 93 5 3 23 4 49 0 3 24 2 07 7 3 24 7 16 7 3 25 1 24 5 3 23 6 51 6 Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 104 9.2 Viral hepatitis WHO used the Global Hepatitis Report, 2017 (34) as the baseline for all indicators except HBV incidence, which was obtained from the CDA Foundation’s (CDAF) Polaris Observatory. Incidence and mortality measures were calculated against a denominator of the total population in 2019. Current average number of diagnostic tests and prices for diagnosis and treatment were applied. For hepatitis C, treatment costs reflect the full course (3 months) of therapy. Sustained virological response (SVR) is assumed to be 95% and mortality rate 1.45%. Target diagnosis and treatment rates are shown in Tables 9 and 10, respectively. Table 9. HBV estimated annual costs per person per intervention and treatment coverage Cost, Rate 2022 2023 2024 2025 2026 2027 2028 2029 2030 Cost (US$) Screening cost 1.99 0.87 0.86 0.79 0.78 0.75 0.73 0.69 0.65 Laboratory costs – treatment eligible 18 15 15 15 15 15 15 15 15 Laboratory costs – treatment ineligible 18 15 15 15 15 15 15 15 15 Treatment cost (annual) 55.99 86.61 83.62 68.22 64.02 58.72 52.08 43.81 33.60 Rate (%) Target diagnosis rate 10 17 27 39 54 68 79 86 90 Target treatment eligible rate 33 35 39 43 48 53 56 59 60 Target treatment rate 102 100 97 94 90 86 83 81 80 Mortality change 93 88 81 72 61 51 43 38 35 Mortality rate – all causes 0.86 0.88 0.91 0.94 0.91 0.94 0.96 0.99 1.03 Incidence change 75 70 62 51 39 28 19 13 10 Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 105 Table 10. HCV estimated annual costs per person per intervention and treatment coverage Cost, rate 2022 2023 2024 2025 2026 2027 2028 2029 2030 Cost (US$) Screening cost 1.07 0.77 0.77 0.73 0.72 0.71 0.69 0.67 0.65 Laboratory costs 18 15 15 15 15 15 14 14 14 Treatment cost per person 95 77 77 75 74 74 73 71 70 Treatment cost total 671.15 405.97 405.97 373.35 364.44 353.21 339.14 321.63 300.00 Rate (%) Target diagnosis rate 13 19 27 36 46 58 71 81 90 Target treatment rate 14 19 26 33 42 53 63 73 80 Average SVR 95 95 95 95 95 95 95 95 95 Mortality change 105 100 93 85 75 64 53 43 35 Mortality rate (all causes) 1.45 1.45 1.45 1.45 1.45 1.45 1.45 1.45 1.45 Incidence change 81 75 68 60 50 39 28 18 10 SVR – sustained virological response Table 11 and Fig. 18 give the HBV and HCV elimination programme cost till 2030. Table 11. HBV and HCV elimination programme cost in WHO SE Asia Region: 2020–2030 (‘000 US$) 2020 2025 2028 2030 HBV HCV screening cost 9202 240 499 302 019 190 809 HBV HCV lab cost 11 778 343 913 644 709 697 375 HBV HCV treatment cost 81 096 684 719 1 259 941 966 482 Total HBV & HCV programme cost 102 076 1 269 131 2 206 670 1 854 666 Fig. 18. HBV and HCV elimination programme estimated cost in WHO SE Asia Region: 2020–2030 (‘000 US$) Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 106 9.3 STI WHO used interim 2020 estimates for incidence and prevalence rates of four curable STI. Treatment of complications of untreated STI, such as pelvic inflammatory disease (PID), was quantified as 20% of untreated female incident gonorrhoea and chlamydia episodes (35,36). Clinical STI management was costed according to WHO STI treatment guidelines, with increasing aetiological management over time. Most unit costs were held constant from 2020 to 2030, with price declines for gonorrhoea and chlamydia testing assumed. Additional costs of 14% were applied for intervention implementation costs. For all interventions and activities, a linear coverage scale-up from 2020 baseline to 2025 targets and between 2025 and 2030 targets was assumed. Unit costs for STI diagnostics and medicines were obtained from UNICEF’s Supply Catalogue. Tables 12 and 13 give the service delivery unit costs for STI. Table 12. Service delivery estimated unit costs for STI – stable Service Unit cost (US$) Time trend Syphilis screening: RDT (SD bio line) 0.71 Constant Syphilis RPR confirmation 0.09 Constant Wet mount microscopy: trichomonas 0.39 Constant Herpes GUD treatment: acyclovir 400 mg 1.05 Constant Syphilis treatment: benzathine penicillin 2.4 MU 0.86 Constant Chlamydia (and mycoplasma) treatment: azithromycin 500 mg 0.47 Constant TV and BV treatment: metronidazole 500 mg 0.30 Constant Mild/moderate PID treatment: ceftriaxone + 2 outpatient visits 3.21 Constant Severe PID treatment: ceftriaxone + doxycycline + metronidazole + 2 inpatient days 9.01 Constant Treatment of antibiotic resistant gonorrhoea after first-line treatment failure 25 Falling to 15 by 2030 Outpatient visit to test or treat for primary prevention and partner notification 4.7 Constant Inpatient hospital day: apply two inpatient days per treatment of a severe PID episode 34 Constant HPV vaccination, 2 dosages per patient 42.7 Constant HPV screening, 1 woman 30-49 years of age: ¤ HPV DNA test ¤ Visual inspection with acetic acid ¤ Papanicolaou test 10.1 2.0 1.8 Constant RDT – rapid diagnostic test; RPR – rapid plasma reagin; GUD – genetic ulcer disease; TV – Trichomonas vaginalis; BV – Bacterial vaginosis Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 107 Table 13. Service delivery estimated unit costs for STI – time varying Year NAAT/GenExpert NG+CT Gonorrhoea treatment Drug for gonorrhoea treatment 2020 16.9 0.95 Ceftriaxone 250 mg 2021 16.9 0.95 Ceftriaxone 250 mg 2022 15.7 1.92 Ceftriaxone 500 mg 2023 14.7 1.02 Ceftriaxone 500 mg 2024 13.7 1.08 Ceftriaxone 1 g 2025 12.7 10.5 50/50 ceftriaxone and new drug 2026 5.7 20 New drug 2027 5.7 20 New drug 2028 3.7 15 New drug price lowered 2029 3.7 15 New drug price lowered 2030 3.7 15 New drug price lowered NAAT – nucleic acid amplification test; NG – Neisseria gonorrhoeae; CT – Chlamydia trachomatis Table 14 gives the treatment resources for the Region. Table 14. Estimated treatment resources for WHO SE Asia Region (million US$) Resource Year Million US$ NAAT testing NG/CT clinic patients 2025 72 Metronidazole treatment, clinics 2025 12 Acyclovir treatment, GUD patients 2025 18 HPV vaccination 2025 78 HPV screening 2025 129 All STI and HPV services 2021 491 2025 1063 2030 1241 Fig. 19 gives the cost projections for the Region for the period 2022–2030. The graph estimates do not include HPV screening or vaccination. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 108 Fig. 19. STI estimated cost projections for South East Asia, based on GHSS 2022–2030 2020 2021 2022 2023 2024 2025 Programme support 22.3 39.3 56.8 74.9 93.7 126.8 Screening, outreach, partner no�fica�on 46.9 123.9 201.5 279.5 358.1 437.2 Case Management 107.6 144.2 183.2 226.2 273.2 422.2 Primary preven�on: FSW, MSM/TG, AGYW, ABYM 4.5 12.8 21.1 29.5 37.9 46.4 0.0 200.0 400.0 600.0 800.0 1000.0 1200.0 US $ (m ill io n) Year Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 109 References 1. Global health sector strategies on, respectively, HIV, viral hepatitis and sexually transmitted infections, 2022–2030. Geneva: World Health Organization; 2022 (https://www.who.int/publications/i/ item/9789240053779, accessed 19 July 2022). 2. Global health sector strategy on viral hepatitis 2016–2021: towards ending viral hepatitis. Geneva: World Health Organization; 2016. 3. 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Geneva: Avenir Health; 2021. 36. Rowley J, Van der Hoorn S. WHO prevalence and incidence estimates, 2020 first round – Gonorrhoea, Chlamydia and Trichomoniasis. Geneva: World Health Organization; 2021. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 111 Annexures Annex 1: Measurement framework Tables A1–A6 present the shared and disease-specific impact indicators and targets across viral hepatitis, HIV and STI and the sources for these data. Additional disease-specific indicators and targets are also presented in Chapter 3 (viral hepatitis), Chapter 4 (HIV) and Chapter 5 (STI), respectively. Table A1. Regional Impact indicators and targets for viral hepatitis, HIV and STI by 2025 and 2030 Disease area Indicator Baseline–2020a Targets–2025 Targets–2030 Viral hepatitis HBsAg prevalence among children younger than 5 years of age (proxy for incidence) 0.94% 0.5% 0.1% Number of new hepatitis B infections per year (incidence) 256 700 (13 per 100 000) 130 000 (5 per 100 000) 42 000 (2.5 per 100 000) Number of new hepatitis C infections per year (incidence) 234 100 (12 per 100 000) 115 000 (6 per 100 000) 80 000 (4 per 100 000) Number of new hepatitis C infections among PWID per year 8 per 100 3 per 100 2 per 100 Number of people dying from hepatitis B per year 179 000 deaths (9 per 100 000) 100 000 deaths (5 per 100 000) 60 000 deaths (3 per 100 000) Number of people dying from hepatitis C per year 38 000 deaths (2 per 100 000) 20 000 deaths (1 per 100 000) 10 000 deaths (0.5 per 100 000) HIV Number of people newly infected with HIV per year 140 000 41 000 35 000 Number of people newly infected with HIV per 1000 uninfected population per year (SDG 3.3.1) C0.05 0.035 0.025 Number of children 0–14 years of age newly infected with HIV per year 9000 3000 1500 Number of people dying from HIV/ related causes per year (including disaggregation by HIV, cryptococcal meningitis, TB and severe bacterial infections) 94 000 32 000 30 000 Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 112 Disease area Indicator Baseline–2020a Targets–2025 Targets–2030 STI Number of new cases of four curable STI in adults (15–49 years) per year ('000) 59 677 47 742 21 273 Number of new cases of syphilis in adults (15–49 years) per year ('000) 354 283 35 Number of new cases of gonorrhoea in adults (15–49 years) per year ('000) 21 059 16 847 2106 Congenital syphilis cases per 100 000 live births per year 145 <200 <50 Table A2. Regional Integration indicators and targets for viral hepatitis, HIV and STI for SE Asia by 2025 & 2030 Integration indicator Baseline 2020 2025 target 2030 target Source(s) Number of countries that have taken a political decision to integrate the three national programmes of HIV, hepatitis and STI 2 8 11 MoH Countries which have prepared fully- costed NSPs for integrated response and identified finances for funding the same 0 8 11 MoH Countries where the three programmes have been brought under a common umbrella of governance 4 8 11 MoH Countries where the health workforce of the three programmes have been retrained to work across all the three programmes 0 8 11 MoH Countries where the CHWs have been given legal status and recognition at par with government health workers 1 3 11 MoH Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 113 Ta bl e A 3. Re gi on al Im pa ct a nd c ov er ag e in di ca to rs , t ar ge ts a nd m ile st on es fo r vi ra l h ep at iti s in S E A si a by 2 02 5 & 2 03 0 In di ca to r Ba se lin e – 20 20 a Ta rg et s – 20 25 Ta rg et s – 20 30 Di sa gg re ga tio n So ur ce (s) Im pa ct HB sA g pr ev ale nc e a m on g ch ild re n yo un ge r th an 5 y ea rs o f a ge b (p ro xy fo r inc ide nc e) – 0. 94 % 0. 5% 0. 1% Ag e, se x, ge og ra ph y Se e s ou rce de tai ls an d m et ho do log y i n W HO C ou nt ry Gu ide lin es fo r th e v ali da tio n o f th e e lim ina tio n of vi ra l h ep ati tis (2 5) Nu m be r o f n ew he pa tit is B i nf ec tio ns pe r y ea r ( inc ide nc e) 25 6 70 0 (1 3 pe r 10 0 00 0) 13 0 00 0 (5 p er 1 00 0 00 ) 42 0 00 (2 .5 p er 1 00 0 00 ) Ag e, se x, ge og ra ph y Nu m be r o f n ew he pa tit is C inf ec tio ns pe r y ea r ( inc ide nc e) 23 4 10 0 (1 2 pe r 10 0 00 0) 11 5 00 0 (6 p er 1 00 0 00 ) 80 00 0 (4 p er 1 00 0 00 ) Ag e, se x, ge og ra ph y, pr ior ity po pu lat ion Nu m be r o f n ew he pa tit is C inf ec tio ns am on g PW ID p er ye ar 8 pe r 10 0 3 pe r 10 0 2 pe r 10 0 Ag e, se x Nu m be r o f p eo ple d yin g fro m he pa tit is B p er ye ar 17 9 00 0 de at hs (9 p er 1 00 0 00 ) 10 0 00 0 de at hs (5 p er 1 00 0 00 ) 60 00 0 d ea th s (3 p er 1 00 0 00 ) Ag e, se x, cir rh os is or ca nc er st atu s Nu m be r o f p eo ple d yin g fro m he pa tit is C pe r y ea r 38 00 0 d ea th s (2 p er 1 00 0 00 ) 20 00 0 d ea th s (1 p er 1 00 0 00 ) 10 0 00 d ea th s (0 .5 p er 1 00 0 00 ) Ag e, se x, cir rh os is or ca nc er st atu s Co ve ra ge He pa tit is B – p er ce nt ag e o f p eo ple liv ing w ith he pa tit is B d iag no se dc / an d tre ate d (in itia te d vs vi ra l lo ad su pp re ssi on ) 10 .5 % /4 .5 % 60 % /5 0% 90 %/ 80 % Ag e, se x, pr ior ity po pu lat ion Na tio na l pr og ra m m e He pa tit is C – p er ce nt ag e o f p eo ple liv ing w ith he pa tit is C dia gn os ed /cu re d 9% /7 % 60 % /5 0% 90 %/ 80 % Ag e, se x, pr ior ity po pu lat ion Na tio na l pr og ra m m e Pe rce nt ag e o f n eo na te s w ho ha ve be ne fit te d fr om a t im el y he pB -B D va cc ine an d fro m o th er in te rve nt ion s t o pr ev en t t he ve rti ca l (m ot he r-t o- ch ild ) tra ns m iss ion o f h ep ati tis B vir us d 54 % 70 % 90 % Ag e, se x, pr ior ity po pu lat ion W UE NI C He pa tit is B v ac cin e c ov er ag e a m on g ch ild re n (t hi rd d os e) in t ho se < 1 ye ar of ag e 91 % 90 % 90 % Ag e, se x, pr ior ity po pu lat ion W UE NI C Nu m be r o f n ee dle s a nd sy rin ge s dis tri bu te d pe r P W ID e ( co m m on H IV / vir al he pa tit is ind ica to r) 15 7 20 0 30 0 Se x Na tio na l pr og ra m m e Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 114 Pe rce nt ag e o f o pio id- de pe nd en t P W ID wh o re ce ive O ST 2. 8% - 1 9. 5% f 40 % 40 % Ag e, se x Na tio na l pr og ra m m e Blo od sa fet y – p ro po rti on o f b loo d un its sc re en ed fo r b loo db or ne d ise as es 80 % 10 0% 10 0% Ge og ra ph y Na tio na l pr og ra m m e Sa fe inj ec tio ns – pr op or tio n o f s afe he alt h- ca re in jec tio ns 94 .8 % 10 0% 10 0% Ge og ra ph y Na tio na l pr og ra m m e M ile sto ne s Pl an ni ng – nu m be r o f c ou nt rie s w ith co ste d he pa tit is eli m ina tio n p lan s 2 11 11 N/ A M oH Su rv eil lan ce – nu m be r o f c ou nt rie s re po rti ng b ur de n a nd ca sc ad e a nn ua lly 3 8 11 N/ A M oH Eli m in at io n of ve rti ca l ( m ot he r- to -c hi ld ) t ra ns m iss io n – n um be r o f co un tri es va lid ate d fo r t he el im ina tio n of ve rti ca l t ra ns m iss ion o f e ith er H IV o r he pa tit is B o r s yp hil is 3 5 11 N/ A M oH Eli m in at io n – n um be r o f c ou nt rie s va lid ate d fo r e lim ina tio n o f h ep ati tis C an d/ or he pa tit is B 0 2 11 N/ A M oH In te gr at io n – pr op or tio n of P LH IV te ste d fo r/a nd cu re d fro m he pa tit is C Un re po rte d 60 % /5 0% 90 %/ 80 % N/ A M oH W U EN IC – W H O /U N IC EF e st im at es o f n at io na l i m m un iz at io n co ve ra ge a La te st d at a fo r en d 20 20 . S om e ta rg et s us e da ta fr om 2 01 9 be ca us e of C O VI D -1 9 re la te d se rv ic e di sr up tio ns in th e da ta rep or ted fo r 2 02 0. b Ple as e n ot e t ha t t he ta rg ets in th is tab le are ba se d o n g lob al tar ge ts an d s ho uld be ad ap ted to se t t arg ets fo r c ou nt rie s i n rel ati on to th e n ati on al co nt ex t. F or ex am ple , in so me co un tri es a tar ge t f or H Bs Ag pr ev ale nc e a mo ng ch ild ren yo un ge r th an 5 y ea rs m ay b e le ss th an 0 .1 % o r 0. 2% , a lth ou gh th e ov er al l r eg io na l t ar ge t s ho ul d be 0 .1 % . c D en om in at or is e st im at ed n um be r of p eo pl e liv in g w ith h ep at iti s B vi ru s (s ta nd ar di ze d po pu la tio n es tim at e) . d In a dd iti on , t he p ro po rt io n of in fa nt s yo un ge r th an 1 2 m on th s of a ge w ho r ec ei ve d th e th ird d os e of h ep at iti s B va cc in e sh ou ld als o b e m ea su red as w ell as ot he r in dic ato rs fo r p rev en tin g v ert ica l tr an sm iss ion , s uc h a s m ate rn al tes tin g a nd pr op hy lax is. e As pa rt of a co mp reh en siv e h arm re du cti on st rat eg y a nd in lin e w ith na tio na l p rio rit ies . f W ide va ria tio n b etw ee n c ou nt rie s i n t he Re gio n ( no t a ll c ou nt rie s r ep or tin g) . Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 115 Pe rce nt ag e o f o pio id- de pe nd en t P W ID wh o re ce ive O ST 2. 8% - 1 9. 5% f 40 % 40 % Ag e, se x Na tio na l pr og ra m m e Blo od sa fet y – p ro po rti on o f b loo d un its sc re en ed fo r b loo db or ne d ise as es 80 % 10 0% 10 0% Ge og ra ph y Na tio na l pr og ra m m e Sa fe inj ec tio ns – pr op or tio n o f s afe he alt h- ca re in jec tio ns 94 .8 % 10 0% 10 0% Ge og ra ph y Na tio na l pr og ra m m e M ile sto ne s Pl an ni ng – nu m be r o f c ou nt rie s w ith co ste d he pa tit is eli m ina tio n p lan s 2 11 11 N/ A M oH Su rv eil lan ce – nu m be r o f c ou nt rie s re po rti ng b ur de n a nd ca sc ad e a nn ua lly 3 8 11 N/ A M oH Eli m in at io n of ve rti ca l ( m ot he r- to -c hi ld ) t ra ns m iss io n – n um be r o f co un tri es va lid ate d fo r t he el im ina tio n of ve rti ca l t ra ns m iss ion o f e ith er H IV o r he pa tit is B o r s yp hil is 3 5 11 N/ A M oH Eli m in at io n – n um be r o f c ou nt rie s va lid ate d fo r e lim ina tio n o f h ep ati tis C an d/ or he pa tit is B 0 2 11 N/ A M oH In te gr at io n – pr op or tio n of P LH IV te ste d fo r/a nd cu re d fro m he pa tit is C Un re po rte d 60 % /5 0% 90 %/ 80 % N/ A M oH W U EN IC – W H O /U N IC EF e st im at es o f n at io na l i m m un iz at io n co ve ra ge a La te st d at a fo r en d 20 20 . S om e ta rg et s us e da ta fr om 2 01 9 be ca us e of C O VI D -1 9 re la te d se rv ic e di sr up tio ns in th e da ta rep or ted fo r 2 02 0. b Ple as e n ot e t ha t t he ta rg ets in th is tab le are ba se d o n g lob al tar ge ts an d s ho uld be ad ap ted to se t t arg ets fo r c ou nt rie s i n rel ati on to th e n ati on al co nt ex t. F or ex am ple , in so me co un tri es a tar ge t f or H Bs Ag pr ev ale nc e a mo ng ch ild ren yo un ge r th an 5 y ea rs m ay b e le ss th an 0 .1 % o r 0. 2% , a lth ou gh th e ov er al l r eg io na l t ar ge t s ho ul d be 0 .1 % . c D en om in at or is e st im at ed n um be r of p eo pl e liv in g w ith h ep at iti s B vi ru s (s ta nd ar di ze d po pu la tio n es tim at e) . d In a dd iti on , t he p ro po rt io n of in fa nt s yo un ge r th an 1 2 m on th s of a ge w ho r ec ei ve d th e th ird d os e of h ep at iti s B va cc in e sh ou ld als o b e m ea su red as w ell as ot he r in dic ato rs fo r p rev en tin g v ert ica l tr an sm iss ion , s uc h a s m ate rn al tes tin g a nd pr op hy lax is. e As pa rt of a co mp reh en siv e h arm re du cti on st rat eg y a nd in lin e w ith na tio na l p rio rit ies . f W ide va ria tio n b etw ee n c ou nt rie s i n t he Re gio n ( no t a ll c ou nt rie s r ep or tin g) . Ta bl e A 4. Re gi on al im pa ct a nd c ov er ag e in di ca to rs , t ar ge ts a nd m ile st on es fo r H IV in S E A si a, b y 20 25 a nd 2 03 0 In di ca to r Ba se lin e – 20 20 a Ta rg et s – 20 25 Ta rg et s – 20 30 Di sa gg re ga tio n So ur ce (s) Im pa ct in di ca to rs Nu m be r o f p eo ple ne wl y inf ec te d wi th H IV p er ye ar 14 0 0 00 41 00 0 35 00 0 Ag e, se x, pr ior ity po pu lat ion , pr ov inc e/ sta te W HO /U NA ID S re po rti ng Nu m be r o f p eo ple ne wl y in fe ct ed w ith H IV p er 1 00 0 un inf ec te d po pu lat ion p er ye ar (S D G 3 .3 .1 ) 0.0 5 0.0 35 0.0 25 Ag e, se x, pr ior ity po pu lat ion , pr ov inc e/ sta te W HO /U NA ID S re po rti ng Nu m be r o f c hi ld re n 0– 14 y ea rs of ag e n ew ly inf ec te d wi th H IV pe r y ea r 90 00 30 00 15 00 Ag e, se x, pr ior ity po pu lat ion , pr ov inc e/ sta te W HO /U NA ID S re po rti ng Nu m be r o f p eo ple d yin g fro m HI V/ re lat ed ca us es p er ye ar b (in clu din g dis ag gr eg ati on b y HI V, cry pt oc oc ca l m en ing itis , T B an d se ve re b ac te ria l in fec tio ns ) 94 00 0 32 00 0 30 00 0 Ag e, se x, pr ior ity po pu lat ion , pr ov inc e/ sta te W HO /U NA ID S re po rti ng Nu m be r o f c ou nt rie s v ali da te d fo r t he el im ina tio n o f v er tic al (m ot he r-t o- ch ild ) t ra ns m iss ion of H IV , h ep ati tis B, o r s yp hil is 3 5 11 Ag e, se x, pr ior ity po pu lat ion W HO Co ve ra ge in di ca to rs Pe rc en ta ge o f P LH IV w ho k no w th eir H IV st atu sc 77 % 95 % 95 % Ag e, se x, pr ior ity po pu lat ion , pr ov inc e/ sta te Na tio na l pr og ra m m es , co m m un ity -le d m on ito rin g Pe rc en ta ge o f p eo ple w ho kn ow th eir H IV -p os itiv e s tat us an d ar e a cc es sin g AR Tc 78 % 95 % 95 % Ag e, se x, pr ior ity po pu lat ion , pr ov inc e/ sta te W HO /U NA ID S re po rti ng Pe rc en ta ge o f P LH IV r ec ei vi ng tre atm en t, w ho ha ve su pp re sse d vir al loa ds c 91 % 95 % 95 % Ag e, se x, pr ior ity po pu lat ion , pr ov inc e/ sta te W HO /U NA ID S re po rti ng Pe rc en ta ge o f p eo ple at ri sk of H IV w ho us e c om bin ati on pr ev en tio n w ith a d efi ne d se rvi ce p ac ka ge d Va rie s b y k ey po pu la tio n. It is < 50 % on av er ag e 95 % 95 % Ag e, se x, pr ior ity po pu lat ion , pr ov inc e/ sta te W HO /U NA ID S re po rti ng Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 116 In di ca to r Ba se lin e – 20 20 a Ta rg et s – 20 25 Ta rg et s – 20 30 Di sa gg re ga tio n So ur ce (s) Co nd om /lu br ica nt u se at la st se x w ith a cli en t o r n on -re gu lar pa rtn er Va rie s b y k ey po pu lat ion 90 % 90 % Ag e, se x, pr ior ity po pu lat ion W HO /U NA ID S re po rti ng , co m m un ity -le d m on ito rin g Nu m be r o f n ee dle s o r s yri ng es dis tri bu te d pe r P W ID e – co m m on H IV /v ira l h ep ati tis ind ica to r 15 7 20 0 30 0 Pr ov in ce /s ta te W HO /U NA ID S re po rti ng Pe rc en ta ge o f P LH IV a nd pe op le at ris k w ho ar e l ink ed to in te gr ate d he alt h s er vic es , inc lud ing ST I a nd vi ra l h ep ati tis Un re po rte d 95 % 95 % Pr io rit y p op ul at io n Na tio na l pr og ra m m es M ile sto ne s St ig m a a nd d isc rim in at io n – p er ce nt ag e o f p eo ple liv ing wi th vi ra l h ep ati tis , H IV an d ST I a nd p rio rit y p op ula tio ns wh o ex pe rie nc e s tig m a a nd dis cri m ina tio n Pa rti all y r ep or te d Le ss th an 10 % Le ss th an 10 % Pr io rit y g ro up M oH , co m m un ity le d m on ito rin g La ws an d po lic ies – pe rce nt ag e of co un tri es th at ha ve p un itiv e law s a nd p oli cie s Va rie d by po pu lat ion <3 <1 By la w an d pr ior ity po pu lat ion Pu bl ish ed re gu lat io ns Ge nd er – pr ev ale nc e o f r ec en t (p as t 12 m on th s) c as es o f int im ate p ar tn er vi ole nc e am on g pe op le a ge d 15 –4 9 ye ar s Un re po rte d <2 0% Le ss th an 10 % Ag e, pr io rit y po pu lat ion Su rv ey In te gr at io n – P er ce nt ag e o f pe op le liv ing w ith vi ra l h ep ati tis , HI V an d ST I li nk ed to o th er int eg ra te d he alt h s er vic es Un re po rte d 95 % 95 % Ag e, se x, pr ior ity po pu lat ion Na tio na l pr og ra m m es Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 117 In di ca to r Ba se lin e – 20 20 a Ta rg et s – 20 25 Ta rg et s – 20 30 Di sa gg re ga tio n So ur ce (s) Ad va nc ed H IV d ise as e – pe rce nt ag e o f p eo ple st ar tin g A RT w ith a C D 4 co un t of le ss th an 20 0 c ell s/m m 3 ( or st ag e I II or IV ) f 30 % 20 % 10 % Ag e, se x, pr ior ity po pu lat ion Na tio na l pr og ra m m es D iff er en ti at ed s er vi ce d el iv er y – p er ce nt ag e o f c ou nt rie s t ha t ha ve im ple m en te d a 6 -m on th ly re fil l o f d ru gs 0 50 % 80 % Na tio na l pr og ra m m es a La te st d at a fo r en d 20 20 . S om e ta rg et s us e da ta fr om 2 01 9 be ca us e of C O VI D -1 9 re la te d se rv ic e di sr up tio ns in th e da ta r ep or te d fo r 20 20 . b Di sa gg reg ate d b y d ise as e c oin fec tio n. c Ac hie ve d i n a ll a ge s, se xe s a nd fo cu s p op ula tio ns d SW [6 7– 83 % ]; M SM [5 7– 95 % ]; PW ID [2 2– 66 % ]; TG [6 8– 92 % ] i n re po rt in g co un tr ie s. e As pa rt of a co mp reh en siv e h arm re du cti on st rat eg y a nd in lin e w ith na tio na l p rio rit ies . f so a ll PL H IV s ho ul d re ce iv e a CD 4 te st r es ul t. Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 118 Ta bl e A 5. Im pa ct a nd c ov er ag e in di ca to rs , t ar ge ts a nd m ile st on es fo r ST I b y 20 25 a nd 2 03 0 In di ca to r Ba se lin e – 20 20 a Ta rg et s – 20 25 Ta rg et s – 20 30 Di sa gg re ga tio n So ur ce (s) Nu m be r o f n ew ca se s o f f ou r c ur ab le ST I in ad ult s (1 5– 49 y ea rs ) p er y ea r ('0 00 ) 5 9 67 7 4 7 74 2 2 1 27 3 Ag e, se x, pr ior ity po pu lat ion , g eo gr ap hy Na tio na l pr og ra m m es N um be r of n ew c as es o f s yp hi lis in a du lts (1 5– 49 y ea rs ) pe r ye ar (' 00 0) 3 54 28 3 3 5 Ag e, se x, pr ior ity po pu lat ion , g eo gr ap hy Na tio na l pr og ra m m es N um be r of n ew c as es o f g on or rh oe a in a du lts (1 5– 49 ye ar s) p er y ea r ('0 00 ) 2 1 05 9 1 6 84 7 2 10 6 Ag e, se x, pr ior ity po pu lat ion , g eo gr ap hy Na tio na l pr og ra m m es C on ge ni ta l s yp hi lis c as es p er 1 00 0 00 li ve b irt hs p er ye ar 14 5 <2 00 < 50 Ag e, m ale p ar tn er s, pr ior ity po pu lat ion , g eo gr ap hy Na tio na l pr og ra m m es Pe rce nt ag e o f g irls fu lly va cc ina te d wi th H PV va cc ine by 1 5 ye ar s of a ge 14 % 50 % 90 % Pr ior ity p op ula tio n, ge og ra ph y W UE NI C Pe rce nt ag e o f p re gn an t w om en at te nd ing A NC w ho we re sc re en ed fo r s yp hil is/ pe rce nt ag e t re ate d if po sit ive 65 % /7 1% > 85 % /> 90 % > 95 % /> 95 % Ag e, se x, pr ior ity po pu lat ion , g eo gr ap hy (d ist ric t) Na tio na l pr og ra m m es Pe rce nt ag e o f p rio rit y p op ula tio ns b s cre en ed fo r sy ph ilis /p er ce nt ag e t re ate d if p os itiv e No d ata /n o da ta >8 0% /> 90 % > 90 % /> 95 % Ag e, se x, pr ior ity po pu lat ion , g eo gr ap hy Na tio na l pr og ra m m es , co m m un ity - led m on ito rin g Pe rce nt ag e o f p rio rit y p op ula tio ns b s cre en ed fo r go no rrh oe a/ pe rce nt ag e t re ate d if p os itiv e No d ata /n o da ta >2 0% /> 90 % > 90 % /> 95 % Ag e, se x, pr ior ity po pu lat ion , g eo gr ap hy Na tio na l pr og ra m m es , co m m un ity - led m on ito rin g Pe rce nt ag e o f w om en sc re en ed fo r c er vic al ca nc er us in g a hi gh -p er fo rm an ce t es t, by t he a ge o f 3 5 an d ag ai n by 4 5 No d ata / > 40 % /> >7 0% / Ag e, se x, pr ior ity po pu lat ion , g eo gr ap hy Na tio na l pr og ra m m es Nu m be r o f c ou nt rie s r ep or tin g AM R in Ne iss er ia go no rrh oe ae to G AS P 36 % >6 0% >7 0% Co un try M oH A M R pr og ra m m e Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 119 In di ca to r Ba se lin e – 20 20 a Ta rg et s – 20 25 Ta rg et s – 20 30 Di sa gg re ga tio n So ur ce (s) Pla nn ing : n um be r o f W HO M em be r S tat es w ith na tio na l S TI p la ns u pd at ed w ith in t he p as t 5 ye ar s 50 % >7 0% >9 0% Co un try M oH Po lic ies : n um be r o f W HO M em be r S tat es w ith na tio na l ST I c as e m an ag em en t g uid eli ne s u pd ate d wi th in th e pa st 3 y ea rs 40 % >7 0% >9 0% Co un try M oH Su rve illa nc e: nu m be r o f c ou nt rie s w ith st ro ng ST I su rve illa nc e s ys te m sc No d ata 5 11 Co un try M oH GA SP – Go no co cc al An tim icr ob ial Su rve illa nc e P ro gr am me a La te st d at a fo r en d 20 20 . S om e ta rg et s us e da ta fr om 2 01 9 be ca us e of C O VI D -1 9 re la te d se rv ic e di sr up tio ns in th e da ta r ep or te d fo r 20 20 . b Pr io rit y po pu la tio ns a re d efi ne d by in di vi du al c ou nt rie s; fo r sc re en in g in cl ud e m en w ho h av e se x w ith m en , s ex w or ke rs a nd p eo pl e liv in g w ith H IV . c A str on g s ur ve illa nc e s ys tem fo r s ex ua lly tr an sm itt ed in fec tio ns in co rp or ate s f ou r c or e c om pe ten cie s: ca se re po rti ng , re gu lar pr ev ale nc e a sse ssm en ts am on g a nt en ata l c are , m en an d p rio rit y p op ula tio ns , re gu lar an nu al rev iew s o f t he ca us ati on of se xu all y t ran sm itt ed in fec tio n s yn dr om es an d s ym pt om ati c d ata co rre cte d f or un de rre po rti ng , a nd m on ito rin g o f an tim icr ob ial re sis tan ce fo r N eis se ria g on or rh oe a. Ta bl e A 6. Sy ph ilis EM TC T t ar ge ts (2 5) In di ca to r Ta rg et Di sa gg re ga tio n So ur ce (s) EM TC T i m pa ct tar ge t A c as e ra te o f C S of ≤ 50 p er 1 00 0 00 li ve b irt hs NA Na tio na l p ro gr am m es EM CT p ro ce ss tar ge ts ¤ A N C co ve ra ge (a t l ea st o ne v is it) o f ≥ 95 % ¤ Co ve rag e o f s yp hil is tes tin g o f p reg na nt w om en of ≥ 95 % a m on g th os e w ho a tt en de d at le as t o ne A N C vi si t ¤ Ad eq ua te sy ph ilis tr ea tm en t o f s yp hil is- se ro po sit ive pr eg na nt w om en o f ≥ 95 % NA Na tio na l p ro gr am m es CS – co ng en ita l s yp hil is Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 120 Annex 2: Summary of required impact and process targets for country validation of EMTCT of HIV, syphilis and HBV (25) Summary of required impact and process targets for country validation of EMTCT of HIV, syphilis and HBV is given below. 1. EMTCT impact targets ¤ MTCT rate of HIV of <2% in non-breastfeeding populations or <5% in breastfeeding populations ¤ a population case rate of new paediatric HIV infections due to MTCT of ≤50 cases per 100 000 live births ¤ a case rate of congenital syphilis of ≤50 per 100 000 live births ¤ HBsAg prevalence of ≤0.1% in the ≤5-year-old birth cohort (and older children)a ¤ in countries that provide targeted and timely HepB-BD, an additional impact target of HBV MTCT rate of ≤2% should be utilized. 2. EMTCT PROCESS targets (Must be the most recent verified data and must be achieved for two consecutive years) 3. Maternal ANC and testing coverage ¤ ≥95% ANC coverage (at least one visit) (ANC-1) ¤ ≥95% coverage of HIV testing of pregnant women ¤ ≥95% coverage of syphilis testing of pregnant women in ANC ¤ ≥90% coverage of HBsAg antenatal testing among pregnant women. 4. Maternal treatment ¤ ≥95% ART coverage of pregnant women living with HIV ¤ ≥95% adequate treatment of syphilis-seropositive pregnant women ¤ ≥90% coverage with antivirals for eligible HBsAg-positive pregnant women with high viral loads (plus coverage of HBV-exposed babies with HBIg, where available). 5. Infant HBV vaccination ¤ ≥90% coverage with three doses of HBV infant vaccinations (HepB3)b ¤ ≥90% HepB timelyc BD coverage (with universal programme) or infants at riskd (with targeted and timely HepB-BD). Explanatory notes a Childhood prevalence is a proxy for HBV incidence. The ≤0.1% HBsAg prevalence can be measured among either 5-year- olds, 1-year-olds or those in ages 1–5 years, according to existing country surveillance and data collection practices. For regions and countries with a long history of high hepatitis B vaccination coverage, e.g. the WHO Region of the Americas and those that already conduct school-based serosurveys, there could be flexibility to conduct serosurveys in older children, >5 years of age. b Generally for vaccination, a 5-year period of sustainability is required to be able to measure impact via serosurveys (39). c Timely birth dose (HepB-BD) is defined as within 24 hours of birth. d At-risk infants are neonates of HBsAg-positive mothers Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 The Integrated Regional Action Plan for viral hepatitis, HIV and sexually transmitted infections in South-East Asia, 2022–2026 (I-RAP) shares a common vision to end the epidemics of viral hepatitis, HIV and STI in the South-East (SE) Asia Region by 2030. The five strategic directions oriented around service delivery, health systems, strategic information, community empowerment and innovations provide the overall guiding framework for country actions to implement the strategies. The integrated approach will help increase quality and efficiency and leverage the full power of primary health care, universal health coverage (UHC) and health systems for impact. It will promote equity and innovation, and advance people-centred and community-driven approaches. The I-RAP provides a comprehensive regional framework of shared and disease-specific actions to guide countries and partners. Individual countries can adapt these actions in relation to local epidemiological and health system contexts, upholding fundamental human rights, including the cross-cutting principle of equality and non-discrimination in the availability, accessibility, acceptability and quality of health services, products, approaches and interventions. The optimal selection of actions and service delivery models should be aligned with broader national strategies within a UHC framework and be responsive to the needs of individuals and local communities without any stigma or discrimination. 9 789290 209683